MAUDE Adverse Event Report: FRESENIUS KABI AG / FENWAL, INC. FENWAL TRANSFER PACK CONTAINER WITH COUPLER - 600 ML ; CONTAINER, EMPTY, FOR COLLECTION & ACCESSORIES OF BLOOD & BLOOD COMPONENTS

Catalog Number 4R2023

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Pt underwent autologous hpc, apheresis cellular therapy product (ctp) collection on (b)(6) 2019.The ctp was received into the hematopoietic stem cell lab (hscl) on (b)(6) 2019 and benched overnight for processing the next morning.Processing of the ctp was initiated on (b)(6) 2019.The ctp was centrifuged per protocol for volume reduction in preparation for cryopreservation.After centrifugation had completed and upon opening the centrifuge to obtain the product from the centrifuge bucket, the bmt lab technologist discovered that the majority of the plasma had leaked from the transfer pack bag into the plastic recovery bag containing the transfer pack suggesting a breach in the transfer pack bag, at the level of the plasma cell separation.No leakage of the product cells out of the transfer pack was observed.The bmt lab technologist initiated cell rescue measures, transferred the product into a secondary 600 ml transfer pack, and completed processing and cryopreservation of the product without incident.Product sterility will be monitored through pre and post-process sterility testing.For the safety of the pt, the hscl lab director requested that the pt undergo a second hpc, apheresis ctp collection.An investigation of the incident was initiated to determine the root cause of the integrity failure.Upon initial visual examination of the transfer pack, no breach in the transfer pack material could be identified.A small volume of water was dispensed into the transfer pack and slight pressure applied to the bag.Upon applying pressure to the transfer pack, fluid was found to be leaking from a pin hole on the lower left near side of the bag.The pin hole could not be visualized without the use of fluid and pressure.The affected lot of transfer pack has been in use for months.This appears to be an isolated incident.Fda safety report id# (b)(4).

• Brand Name: FENWAL TRANSFER PACK CONTAINER WITH COUPLER - 600 ML
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION & ACCESSORIES OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): FRESENIUS KABI AG / FENWAL, INC. ; bad homburg ; GM
• MDR Report Key: 9445829
• MDR Text Key: 170454204
• Report Number: MW5091552
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 4R2023
• Device Lot Number: FA19B28212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 72