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

Model Number X6R2326

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Apheresis procedure for stem cell collection happened.The procedure was going smooth and in its last cycle when a centrifuge leak alarm was received.A blood leak could be seen in the centrifuge compartment.This alarm is a hard stop and the procedure needs to be aborted without re-infusion of blood from the centrifuge to the patient.The collected stem cell/wbc product bag was immediately clamped and then removed by heat seal.The cells were sent to the lab.The attending physician was notified.Upon removal of the breached kit from the amicus machine the spot of the leak was confirmed.This leak was observed in the lower seam of the centrifuge pack in the same location as the previous leaks.Fresenius kabi was notified via phone call and on-line kit performance report of the leak.The patient was stable and discharged home from the hospital post the collection.Manufacturer response for amicus mnc apheresis kit - double needle, amicus mnc apheresis kit - double needle (per site reporter).Fresenius has commented that they have found the manufacturing defect and will start producing new kits.

• 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: 16321666
• MDR Text Key: 309040331
• Report Number: 16321666
• 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: FA22H22134
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2023
• Event Location: Hospital
• 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: 29565 DA
• Patient Sex: Male