MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBWGQ506A2

Device Problem High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer the wbc count is not available, at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Based on information provided by the customer, it has been determined that this incident was already filed as an mdr by terumo bct.This report is a duplicate of mdr 1722028-2020-00056.No event occurred for this report, therefore, there is no further information to provide.Please see 1722028-2020-00056 for investigation of that event.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• MDR Report Key: 10062535
• MDR Text Key: 193050181
• Report Number: 9681839-2020-00060
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 190820AG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other