Perfusor Space infusion pump syringe incompatibility may cause dosing error
B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an infusion pump with potential for serious medication dosing errors (overdose, underdose, delayed therapy). This is a risk-of-harm medical device where injury has not yet been reported, fitting the High severity criterion.
Plain-English summary
B Braun Medical Inc is recalling Perfusor Space infusion pump kits (Model 8713040U). The pump's instructions for use previously identified Cardinal Health Monoject syringes as compatible options for use.
Cardinal Health has made manufacturing changes to their Monoject syringes. These changes affect compatibility with the Perfusor Space pump, causing issues with syringe recognition and pump performance.
Incompatible syringes may result in the following adverse effects: overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. No illnesses or injuries have been reported to date.
Cardinal Health Monoject syringes are not compatible with Perfusor Space pumps and should not be used. Healthcare providers and patients using these devices should verify syringe compatibility before each use and discontinue use of any Monoject syringes with Perfusor Space pumps.
The recalled product
- Product
- Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Hazard
- overdose
- underdose
- incompatibility
- therapy-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 (3)
- Lot Code: Model No 8713040U
- UDI-DI 4046963687182
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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