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

Catalog Number 1BBWGQ506A2

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 09/11/2022

Event Type  malfunction  

Manufacturer Narrative

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.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.Unit id: (b)(6) the device is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: we received red blood cell storage bag only; therefore, we were not able to investigate the filter, which is related to filtration function.The blood in the red blood cell storage bag was discharged from the tubing then filtered through a sieve (mesh size: 90 m).We observed blood aggregates trapped on the sieve.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray is heat-sealed.For the leukoreduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the standards.Shipping testing, including measurements of solution concentration and volume, and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all shipping testing items.The product conformed to the standards.Regarding the retained samples of the lot numbers in question, three sets were visually examined.There were no abnormalities in their appearances.We used one set to measure the solution volume and used another one set to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Root cause: as mentioned above, there were no anomalies in the manufacturing record and the testing and inspection record of the lot number concerned.We were not able to identify the cause of this issue.We were unable to observe the state of the occurrences in the filter, which is related to filtration performance, as the filter was not returned for evaluation.The following cases are cited as possible causes of wbc count failure in general.(1) blood characteristics of a donor (2) white blood cells are leaked out of the filter due to applying pressure to the collection bag or filter during filtering the collected blood.Concerning (2), it is recommended to pay attention to prevent the bags or the filter from being squeezed or pressurized.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.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.Unit id: (b)(4) the device is not available for return because it was discarded by the customer.

• 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: 15609485
• MDR Text Key: 307165262
• Report Number: 9681839-2022-00095
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 211221AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/08/2022
• 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