MAUDE Adverse Event Report: FENWAL, INC.; DISPOSABLE APHERESIS KIT

Catalog Number 4R2023

Device Problems Leak/Splash (1354); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Autologous stem cell product was collected from a patient.During processing, the bag containing the product broke during centrifugation.A small amount of the product leaked and the product sterility may have been compromised.Manufacturer response: the fenwal plasma product performance report has been completed by the company.The fenwal post market quality assurance team has been in contact with our facility.

• Type of Device: DISPOSABLE APHERESIS KIT
• Manufacturer (Section D): FENWAL, INC.; three corporate drive; lake zurich IL 60047
• MDR Report Key: 3986810
• MDR Text Key: 15178443
• Report Number: 3986810
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 4R2023
• Device Lot Number: FA13 | 18099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIFUGE
• Patient Age: 49 YR