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

Catalog Number 1BBLGQ506A6

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.Donor unit #: (b)(6).There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.Terumo bct is awaiting the return of the device.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.Donor unit #: (b)(6) there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: the set in question was not returned for investigation and the lot number concerned was unknown.We therefore conducted the following investigation based on the information provided.In making the blood bags concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.In making leukocyte reduction filters, filter membranes are formed and put in filter housings.The lot number was not specified and we therefore reviewed the manufacturing record for the past five years.We confirmed that machine/equipment trouble which could cause the event had occurred.No abnormalities occurred in any processes, and production was carried out as usual.Blood bags are tested on a sample basis for every lot.Various tests including a visual inspection, the volume measurement of blood preservative solution, and the quantitative test for the composition of the solution, are tested and only the lots that have passed the tests are released.The lot number was not specified and we reviewed the testing and inspection record for the past five years.No abnormalities were observed.Root cause: as the above-mentioned investigation results, the manufacturing record and the testing and inspection record of the past five years did not show any abnormalities that could cause the reported issue; therefore, we were not able to identify the cause of the reported issue.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya 418-0 004; JA 418-0004
• Manufacturer (Section G): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; 818 misonodaira; fujinomiya 418-0 004; JA 418-0004
• Manufacturer Contact: makoto yoshikawa ; 818 misonodaira; fujinomiya 418-0-004 ; JA 418-0004
• MDR Report Key: 15873105
• MDR Text Key: 307913729
• Report Number: 9681839-2022-00106
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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 Catalogue Number: 1BBLGQ506A6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other