MAUDE Adverse Event Report: FRESENIUS KABI AG AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE; DISPOSABLE MNC KIT FOR STEM CELL COLLECTION ON AMICUS MACHINE

Model Number X6R2326

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

The patient was in cycle 6 of her planned 10 cycle collection when a centrifuge blood leak occurred.The procedure immediately stops and the only option given to the nurse is to abort the procedure.Blood from the centrifuge is not able to be re-infused to the patient.The collected product bag and plasma bag were able to be immediately clamped on the alarm happened.The cells were sent to the lab.A second procedure was started up again on a new machine with a new primed, sterile kit and completed successfully.On exam of the disposable kit, the leak was found to be at the seam of the centrifuge pack in the same location as the previous leaks.Fresenius kabi was made aware of the leak today.Manufacturer response for disposable mnc kit for stem cell collection on amicus machine, amicus mnc apheresis kit - double needle (per site reporter).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: DISPOSABLE MNC KIT FOR STEM CELL COLLECTION ON AMICUS MACHINE
• Manufacturer (Section D): FRESENIUS KABI AG; three corporate drive 2nd floor; lake zurich IL 60047
• MDR Report Key: 16321707
• MDR Text Key: 309043712
• Report Number: 16321707
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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: 02/03/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Female