Field Safety Notice B Braun Infusomat Space Transfusion Line – Leakage (ICN 1991)
Important Customer Notice Field Safety Notice
- B Braun has issued a Field Safety Corrective Action Notice after identifying the risk for leakages in four batch numbers of their Infusomat Space Transfusion Lines.
- The potential leakage is located between the tube and the patients’ Luer connector.
- B Braun advise no serious injuries to patients, users, or third parties have been reported to date, however the deviation might harbour the risk for the patient of microbial contamination, under supply, open patient access, or air infusion.
- The product affected is available from NHS Supply Chain:
|NPC||Product Description||Supplier Code / MPC||Batch Numbers|
|FSB2495||Administration set for Infusomat Space Volumatic Pump||8270066SP-01||22F19E8ST5
- Please note only the batch numbers quoted are affected. NHS Supply Chain Warehouses are being checked for these and future deliveries should be of different, unaffected batch numbers.
- B Braun advise this withdrawal should have no impact on future supplies.
- Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
- Cease use and quarantine affected bath numbers. It is recommended to exchange devices of these batch numbers which are currently in use.
- Contact your local NHS Supply Chain Customer Service Advisor with full details of affected, unused, products for return for full credit using reason code 7 Supplier recall. All devices to be returned no later than Friday 3 February 2023.