B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
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 requires a minimum score of 4 (Severe). The defect poses serious risk: false alarms cause the pump to stop delivering high-risk medications, potentially triggering hemodynamic instability and requiring medical intervention to prevent permanent harm or death.
Plain-English summary
B. Braun is recalling the Infusomat Large Volume Pump, Wireless (Model 8713051U), a volumetric infusion pump used to deliver medications intravenously. The recall affects 9,771 units distributed domestically nationwide and in Canada.
The device may sound an upstream occlusion alarm even when no blockage exists. When this false alarm occurs, the pump stops delivering medication. This interruption in infusion of high-risk medications can lead to hemodynamic instability—sudden changes in heart rate and blood pressure—potentially requiring emergency medical intervention.
Interruption to high-risk medication delivery may result in permanent impairment to body structures or functions. In some cases, this malfunction may be life-threatening or could lead to death.
Patients and healthcare providers currently using this device should immediately contact B. Braun Medical, Inc. for instructions. Do not continue using the affected units. Consult your healthcare provider immediately if you believe you have been affected by this defect.
The recalled product
- Product
- 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- false-alarm
- device-malfunction
- medication-interruption
- hemodynamic-instability
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 (13)
- 430119
- 430155
- 430243
- 551518
- 685947
- 703196
- 705968
- 726936
- 737729
- 753364
- 774163
- 790843
- 814074
Distribution
Distributed nationwide across the United States.
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