Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. The defect can interrupt infusion of high-risk medications, leading to hemodynamic instability that may require medical intervention to prevent permanent impairment or death. While no serious injuries or deaths have been reported, the FDA Class I classification combined with the serious potential consequences establishes this as Severe.
Plain-English summary
B. Braun Medical, Inc. is recalling the 8713052U Infusomat Large Volume Pump Non-Wireless Battery Pack, a volumetric infusion pump system used to deliver medications to patients. The recall affects 884 units distributed nationwide in the United States and to Canada.
The device may sound an upstream occlusion alarm even when no blockage exists. When this false alarm occurs, the pump stops delivering medication. Interruption of infusion for high-risk medications can cause hemodynamic instability, which may require medical intervention to prevent permanent damage to organs or body functions.
This is a Class I recall. Patients or healthcare providers using affected devices should contact B. Braun Medical, Inc. immediately. Do not use the device if a false occlusion alarm occurs; seek medical attention for patients who may have experienced an interruption in medication delivery.
The recalled product
- Product
- 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 884
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 (12)
- 133975
- 490442
- 546815
- 559325
- 561645
- 562713
- 593049
- 617405
- 617409
- 618522
- 783680
- 810031
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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