This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that BD and their subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter notifying affected customers of worse performance, under certain use cases, for the BD Alaris Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets.
| Product Name | Catalog/Model (Ref) No. | Software Version | UDI-DI |
|---|---|---|---|
| BD Alaris Pump Module Model 8100 | 8100 | All software versions | 10885403222054 10885403517723 10885403810015 10885403810039 10885403810046 |
| BD Alaris System with Guardrails Suite MX (PCU) | 8015 | All software versions up to v12.5 | 10885403801549 10885403801532 10885403801518 10885403519284 10885403519215 10885403517921 10885403516023 10885403515231 10885403519291 |
| BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites | 10013186 | NA | 07613203021173 |
| BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites | 2452-0007 | NA | 10885403219870 |
| BD Alaris Pump Infusion Set | 2204-0007 | NA | 10885403199363 |
| BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-site | 24001-0007 | NA | 10885403238666 |
| BD Alaris Pump Infusion Burette Set, 0.2 Micron ilter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site | 10015012 | NA | 10885403233951 |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites | 2432-0007 | NA | 10885403232329 |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-site | 2434-0007 | NA | 07613203019682 |
| BD Alaris Pump Infusion Set, 1.2 Micron Filter | 2202-0007 | NA | 10885403274039 |
| BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites | 11426965 | NA | 10885403232558 |
| BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites | 10561554 | NA | 10885403232565 |
| BD Alaris Pump Infusion Set, 15 Micron Filter | 10863358 | NA | 10885403232466 |
| BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites | 11171447 | NA | 07613203021234 |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites | 11532269 | NA | 10885403232343 |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 10010454 | NA | 07613203015806 |
| BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 2465-0007 | NA | 10885403221941 |
| BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 10010453 | NA | 07613203021135 |
What to Do
Refer to the updated set performance data as compared to the existing set performance data found in User Manuals. Follow applicable warnings and recommendations from the User Manual to mitigate risks associated with these infusion parameters. Consider using additional mitigations with the 0.2-micron in-line filter infusion set.
On July 8, BD sent all affected customers a letter recommending the following actions:
- Devices can continue to be used as intended.
- The User Manuals currently provide applicable warnings and recommendations for clinical users to mitigate the risks associated with conditions that shift flow rate accuracy, time to alarm, and bolus accuracy performance.
- Please refer to the recommendations and warnings from the BD Alaris User Manual regarding rate and bolus accuracy, time to alarm, and post-occlusion bolus volume (POBV).
- The following actions should be considered for the 0.2-micron in-line filter infusion set:
- Ensure all clamps are open; there are no kinks or collapses in the tubing outside of the pump; drops are flowing in the drip chamber.
- Avoid infusion flow rates below 1 mL/h.
- Avoid using Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
- Refer to Table 1 for the new set performance data as compared to the existing set performance data found in your User Manuals.
- Post this Customer Notification on or near the affected products. If you experience any issues, contact BD at productcomplaints@bd.com
- Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Table 1. Essential Performance Data Described in BD Alaris with Guardrails Suite MX User Manuals v12.3 - 12.5 compared to New Performance Data
| Performance Metric | A Performance Described in BD Alaris User Manuals v12.31 - 12.5 |
B New Performance Data for pump sets with an in-line filter |
C New Performance Data for pump sets with backcheck valve and SmartSite Y-sites |
|---|---|---|---|
| Flow Rate Accuracy [Flow Rates] |
±5% -8% to +5.5% |
-6% to +5% -12.5% to +5% |
-6% to +5% -8% to +5.5% |
| Bolus Accuracy - Loading Dose2 [Bolus Volumes] |
-3.5% to +3.0% -11.7% to +6.1% 0% to +49.8% |
±4% -5% to +11.5% -15.1% to +102.4% |
-5% to +7% -3% to +10% -12.2% to +96.4% |
| Bolus Accuracy - Subsequent Doses3 [Bolus Volumes] |
±5% ±10% 0% to +55% |
±5% ±10% 0% to +55% |
-6% to +5% ±10% 0% to +55% |
| Downstream Occlusion Time to Alarm4 [Flow Rates] |
5 min or less 59 min or less |
8 min 25 sec or less 1 hour 57 min or less |
5 min 34 sec or less 1 hours 50 min or less |
| Upstream Occlusion Time to Alarm [Flow Rates] |
2 min or less 13 min or less 2 h 22 min or less |
5 min or less 23 min or less 3 h 44 min or less |
5 min or less 23 min or less 3 h 44 min or less |
| Post Occlusion Bolus Volume [Flow Rates] |
0.3 mL or less [0.1 - 999 mL/h] |
0.9 mL or less [0.1 - 999 mL/h] |
0.3 mL or less [0.1 - 999 mL/h] |
- User Manuals for BD Alaris Systems prior to v12.3 disclose performance differently than as presented in column A of Table 1, based on different standards and testing methodology applied prior to v12.3.
- A bolus delivered by the Pump Module at the beginning of an infusion is also known as a loading dose.
- Subsequent bolus dose worst case data is collected without a running continuous infusion.
- Downstream occlusion time to alarm tested with “Pump Mode” pressure setting.
Table 2. BD Alaris Compatible Infusion Sets characterized by New Performance Data
| Product Name | Catalog (Ref) No. | Representative New Performance Data |
|---|---|---|
| BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site | 10015012 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites | 2432-0007 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-site | 2434-0007 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 1.2 Micron Filter | 2202-0007 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites | 11532269 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 10010454 | Table 1, Column B |
| BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 2465-0007 | Table 1, Column B |
| BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site | 10010453 | Table 1, Column B |
| BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site | 24301-0007T | Table 1, Column B |
| BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites | 10013186 | Table 1, Column C |
| BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites | 2452-0007 | Table 1, Column C |
| BD Alaris Pump Infusion Set | 2204-0007 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-site | 24001-0007 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites | 11426965 | Table 1, Column C |
| BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites | 10561554 | Table 1, Column C |
| BD Alaris Pump Infusion Set, 15 Micron Filter | 10863358 | Table 1, Column C |
| BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites | 11171447 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites | 11419365 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites | 10813621 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites | 2423-0007 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite Y-sites | 10015896 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites | 24010-0007 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing | 10010483 | Table 1, Column C |
| BD Alaris Pump Infusion Set, Half Set, SmartSite Y-site | 2403-0007 | Table 1, Column C |
Reason for Early Alert
BD stated that they have identified a subset of compatible pump infusion sets that may perform outside the performance ranges published in the User Manuals for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume (POBV). The deviations in performance from the previously published ranges are attributable to these pump infusion sets' design features, such as filters and other in-line components. Filters with very fine pores (i.e., 0.2 micron) and other in-line components (i.e., back check valves and Y-sites) may impact performance such as flow rate accuracy and time to alarm, particularly at very low flow rates.
The most notable performance variations have been observed with the 0.2-micron in-line filter infusion set at flow rates below 1 mL/h, resulting in upstream time to alarm extending from ≤ 2h 22 min to ≤ 3h 44 min; downstream time to alarm extending from < 59 min to < 1h 57 min; and rate accuracy extending from -8% to 5.5% to -12.5% to 5.5% at very low flow rates. These results are shown in Table 1.
Variations in pump performance, most commonly at programmable rates under 1 mL/h and at or under 1 mL of volume and when infused through the affected subset of compatible infusion sets, can impact infusion delivery in the following ways:
-
Flow rate inaccuracy - over infusion:
Description: The pump delivers fluid or medication at a rate higher than prescribed.
Potential Clinical Outcomes: Drug toxicity, drug overdose, fluid overload, electrolyte disturbances. -
Flow rate inaccuracy - under infusion:
Description: The pump delivers fluid or medication at a rate lower than prescribed.
Potential Clinical Outcomes: Subtherapeutic drug levels leading to ineffective treatment. Delayed therapeutic effects in time sensitive situations. -
Loading bolus dose accuracy - over infusion:
Description: The delivered bolus volume exceeds the intended dose.
Potential Clinical Outcomes: Acute overdose with immediate toxic effects. Increased risk of adverse reactions to drugs particularly ones with narrow therapeutic windows. -
Loading bolus dose accuracy under-infusion:
Description: The delivered bolus volume is less than intended.
Potential Clinical Outcomes: Inadequate response in acute settings. Delay in achieving therapeutic drug levels. -
Upstream and downstream occlusion alarm delay:
Description: Delay in alarm notification due to upstream or downstream occlusion.
Potential Clinical Outcomes: Patients are at risk for missed or delayed treatment. -
Post occlusion bolus volume over infusion:
Description: Upon release of an occlusion, accumulated pressure causes an unintended bolus delivery.
Potential Clinical Outcomes: Sudden administration of a large volume of drug or drug dose, potentially resulting in acute toxicity, overdose, or fluid overload.
The severity and nature of these outcomes depend on the type of medication, fluid, or infusate being administered, as well as the individual patient’s condition.
As of June 11, BD has not reported any serious injuries or deaths associated with this issue.
Device Use
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD at:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
