MAUDE Adverse Event Report: FENWAL, INC. AMICUS MNC APHERESIS KIT ¿ DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number X6R2326

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

During cycle #11 of planned 12 cycle autologous stem cell collection a centrifuge blood leak occurred.The procedure was immediately aborted.The hpc, apheresis cells and plasma were sealed and sent to the bmt lab and not suspected to be contaminated.The patient was unable to have a re-infusion of blood post procedure due to the sterility of the kit being breached.The patient had stable vital signs post collection.A post cbcd was drawn and sent.No blood transfusion post collection is required for him.Manufacturer response for apheresis kit, amicus mnc apheresis kit ¿ double needle (per site reporter).Fresenius kabi was notified via phone call and online submitted kit performance report.

• Brand Name: AMICUS MNC APHERESIS KIT ¿ DOUBLE NEEDLE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): FENWAL, INC.; 3 corporate dr ste 300; lake zurich IL 60047
• MDR Report Key: 16042164
• MDR Text Key: 306071063
• Report Number: 16042164
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• 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: FA22G25121
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male