BD Alaris Infusion Pump Module 8100 May Deliver Inaccurate Doses
The BD Alaris Pump Module 8100 may deliver medication at incorrect flow rates, inaccurate bolus volumes, and may fail to detect occlusions on time. Over 33 million units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum Severe rating. No illnesses or injuries are reported in the source, but the potential for inaccurate medication delivery from flow rate, bolus, and occlusion detection errors in an infusion pump warrants this severity level.
Plain-English summary
The BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software, is under recall by the FDA. The device may perform outside its established operating ranges for medication flow rate, bolus accuracy, occlusion detection timing, and post-occlusion bolus volume.
The recall affects 33,162,680 units distributed nationwide in all U.S. states and territories, plus internationally to Japan, Italy, Germany, and Turkey. These infusion pump modules are used in healthcare settings to deliver medications intravenously.
Healthcare facilities and patients should be aware that an affected device may deliver medication at incorrect rates or volumes and may not alarm appropriately when detecting blockages in the IV line. The inaccuracy in these critical delivery parameters could impact the safe administration of medication.
The recalled product
- Product
- BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- flow-rate-inaccuracy
- bolus-inaccuracy
- occlusion-detection-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054
- 10885403517723
- 10885403810015
- 10885403810039
- 10885403810046
Distribution
Distributed nationwide across the United States.
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