MAUDE Adverse Event Report: FRESENIUS KABI AG AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number X6R2326

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

During cycle #7 of planned 7 cycles of a donor dli collection a blood leak happened in the centrifuge.The collected plasma and product bags were immediately clamped.The procedure was not in cell transfer at the time of the leak and so the collected cells should not have issues with sterility.The procedure was aborted and blood was unable to be re-infused to the donor.The post cbc of the donor was stable, vitals were stable and no medical intervention was required due to blood loss.The procedure ended about 15-20 minutes earlier than expected due to the blood leak.We informed the donor of the issue and answered questions.The leak in the disposable kit appears to be in the exact same location as all the prior centrifuge pack leaks.Fresenius kabi was notified.The bmt lab was notified.Manufacturer response for apheresis kit, amicus mnc apheresis kit - double needle (per site reporter).Previous mnc sets with the same issues were responded to: the manufacturing defect has been determined from fresenius kabi and we expect new kits in the next 2 weeks.

• Brand Name: AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): FRESENIUS KABI AG; three corporate drive; 2nd floor; lake zurich IL 60047
• MDR Report Key: 16361884
• MDR Text Key: 309379649
• Report Number: 16361884
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X6R2326
• Device Catalogue Number: X6R2326
• Device Lot Number: FA22I26141
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Male