Replace on Alert: Infusion Set Efficiency Problem from BD

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products, recommendations for what to do with the devices, and reason for alert below have significant updates.

Affected Product

The FDA is aware that BD and their subsidiary CareFusion have issued two “Urgent Medical Device Recall (Correction)” letters 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. The most recent letter includes additional affected devices, corrective actions, and risk information. New or modified information is marked as “(Updated)” throughout this alert. 

What to Do

(Updated) Clinically appropriate alternate sets should be used and prioritized for use in critical-care, neo-natal, infant, and pediatric care areas. BD’s full customer letter is available on their website.

(Updated) On July 8 and September 11, BD sent all affected customers letters recommending actions. BD’s current recommendations are as follows:

• (Updated) Review your inventory to identify the affected infusion sets.
• (Updated) If alternate BD Alaris Pump infusion sets specific to the use case are available and clinically appropriate, these should be utilized. If alternate sets are limited in quantity, they should be prioritized for use in critical-care, neonatal, infant, and pediatric care areas.

• (Updated) If no alternate infusion sets are available or clinically appropriate, consider using the BD Alaris Syringe Module instead of the BD Alaris Pump Module (or alternative syringe pump if Alaris is not available).
• (Updated) If no alternate BD Alaris Pump infusion sets and no syringe pumps are available, the recalled pump infusion sets may be utilized with caution and enhanced clinical monitoring, while implementing the Risk Mitigation steps from the v12.3 Alaris Infusion System User Manual and summarized below.
• (Updated) If needed, contact BD Clinical Consultants to help with identifying alternative sets, help review customer’s infusion data analytics, and quantify types of infusions infused with specific rate types.
• (Updated) Additional risk mitigations include:
  • (Updated) Rate and Bolus Accuracy: avoid hanging the solution container below the pump module, or higher than 21 inches above the top of the pump module.
  • (Updated) Time to Alarm (TTA): When loading the set ensure tubing is directly over the pressure sensors. 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. Ensure the vent is open if applicable. Avoid using Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
  • (Updated) Post Occlusion Bolus Volume (POBV): When addressing an occlusion (clearing) ensure that the fluid flow to patient is OFF. Disconnect the tubing to relieve excess pressure through a stopcock if present. Weigh the risks of disconnection with the risks of an unintended bolus. 
• 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
• (Updated) For distributors, provide this notice to all customers who may have purchased an Alaris Pump Module.  
• Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue.

(Updated) 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% [1 – 999mL/h] -8% to +5.5% [Less than 1mL/h]	-6%* to +5% [1 – 999mL/h] -12.5%* to +5% [Less than 1 mL/h]	-6%* to +5% [1 – 999mL/h] -8% to +5.5% [Less than 1 mL/h]
Bolus Accuracy – Loading Dose2 [Bolus Volumes]	-3.5% to +3.0% [greater than or equal to 5 mL] -11.7% to +6.1% [1 – less than 5 mL] 0% to +49.8% [Less than 1mL]	±4%* [greater than or equal to 5 mL] -5% to +11.5%* [1 – less than 5 mL] -15.1% to +102.4%* [Less than 1mL]	-5% to +7%* [greater than or equal to 5 mL] -3% to +10%* [1 – less than 5 mL] -12.2% to +96.4%* [Less than 1mL]
Bolus Accuracy – Subsequent Doses3 [Bolus Volumes]	±5% [greater than or equal to 5 mL] ±10% [0.6 – less than 5 mL] 0% to +55% [Less than 0.6 mL]	±5% [greater than or equal to 5 mL] ±10% [1 – less than 5 mL] 0% to +55% [Less than 1mL]	-6%* to +5% [greater than or equal to 5 mL] ±10% [1 – less than 5 mL] 0% to +55% [Less than 1mL]
Downstream Occlusion Time to Alarm4 [Flow Rates]	5 min or less [1 – 999 mL/h] 59 min or less [Less than 1mL/h]	8 min 25 sec or less* [1 – 999 mL/h] 1 hour 57 min or less* [Less than 1mL/h]	5 min 34 sec or less* [1 – 999 mL/h] 1 hours 50 min or less* [Less than 1mL/h]
Upstream Occlusion Time to Alarm [Flow Rates]	2 min or less [5 – 999 mL/h] 13 min or less [1 – less than 5 mL/h] 2 h 22 min or less [Less than 1 mL/h]	5 min* or less [5 – 999 mL/h] 23 min or less* [1 – less than 5 mL/h] 3 h 44 min or less* [Less than 1 mL/h]	5 min* or less [5 – 999 mL/h] 23 min or less* [1 – less than 5 mL/h] 3 h 44 min or less* [Less than 1 mL/h]
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]

1. 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.
2. A bolus delivered by the Pump Module at the beginning of an infusion is also known as a loading dose.
3. Subsequent bolus dose worst case data is collected without a running continuous infusion.
4. Downstream occlusion time to alarm tested with “Pump Mode” pressure setting.
5. (Updated) All performance values out of specification have been marked with an “*”.

(Updated) Table 2. BD Alaris Compatible Infusion Sets characterized by New Performance Data 

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:

1. 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.
2. 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. 
3. 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.
4. 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.
5. 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.
6. 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.

(Updated) 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. Potential outcomes include death and serious adverse events. Vulnerable populations, such as neonates and critically ill patients, are at especially high risk.

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.

Additional FDA Resources

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.  

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.