Infusomat Space Infusion Pump Recall Due to Sensor Malfunction
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
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: This is an FDA Class I recall, which requires a minimum severity score of 4. Although no injuries or deaths have been reported, the potential for device malfunction in a critical infusion system that delivers medication justifies the Severe classification.
Plain-English summary
B Braun Medical Inc is recalling the Infusomat Space Infusion System/Large Volume Pump (Product Code 8713050U) due to a potential malfunction in the upstream occlusion sensor. The sensor can cease proper function due to buildup of electrostatic charge during normal operation, which can trigger false occlusion alarms (both downstream and upstream).
Fourteen units have been distributed in the United States to facilities in Alabama, California, Georgia, Illinois, Michigan, and Texas. Specific serial numbers have been identified for the affected units.
This recall extends a previous recall (RES 92978) as additional devices have been identified as affected. Facilities and healthcare providers with these devices should contact B Braun Medical Inc immediately for recall details and guidance.
The recalled product
- Product
- Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Hazard
- occlusion-sensor-malfunction
- false-alarm
- medication-delivery-error
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 (14)
- UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226
- 107529
- 123259
- 123815
- 123843
- 139003
- 147678
- 147721
- 147725
- 239018
- 239165
- 239231
- 239279
- 339337
Distribution
Distributed in 6 states:
- AL
- CA
- GA
- IL
- MI
- TX
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