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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
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TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER Back to Search Results
Catalog Number 1BBLGQ506A6
Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
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.Donor unit #: (b)(6).
 
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: we received one collection bag with the leukocyte-removing filter (hereinafter referred to as ¿filter¿).We visually confirmed that the filter was connected in the correct direction and there were no abnormalities such as occlusion in the tubing connected to the filter.We also visually checked a small amount of blood remaining in the collection bag and no blood clots were observed.We cut the tubing connected to the outlet port of the filter and discharged blood on a testing sieve (mesh size: 90 m, mesh: no.170) as much as possible.Blood clots or foreign matters were not observed.A soft bag containing normal saline was connected to the inlet of the filter to rinse the remaining blood inside the filter with normal saline flowed by gravity, then we took out eight filter membranes placed inside the filter assembly one by one and put them on a waste cloth for further observation, but we did not observe the attachment of blood clots.In order to examine the state of trapped white blood cells in the filter membranes, all the filter membranes were stained with toluidine blue*.We observed the state of staining and confirmed that the whole area of the pre-membrane was stained blue.In the main membranes, blue stain was observed only near the lower part of the filter media.In regard to the filter media used for the leukocyte-removing filter assembly of the product in question, the filter is formed (membrane making process) followed by the cutting process, warming process, staking and punching process, and housing assembling process.The filter has two types of membranes that have different pores ¿ pre-membrane and main membrane.With regard to the leukocyte-removing filter used for the product in question, one pre-membrane and seven main-membranes are used.Regarding the leukoreduction performance of the filter concerned, particulate removal rates are tested as in-process control and are confirmed to meet the test standards.We reviewed the test record of the particulate removal rates of the filter used for the product concerned.It was confirmed that the particulate removal rates of the pre-membrane tended to be close to the upper limit of the specifications and the particulate removal rates of the cut main membrane tended to be close to the lower limit; however, all the results met the specifications.We also reviewed the record of the manufacturing process of the leukocyte-removing filter product and did not observe any abnormalities or deviations that could affect product quality.For release testing of the product concerned, the blood preservative solution was tested on quantitative tests of sodium citrate hydrate, citric acid hydrate, sodium dihydrogen phosphate, and dextrose, and on net volume measurement and they were satisfied.We reviewed the testing and inspection record of the reported lot number and confirmed that the results of the tests mentioned above conformed to the standards.We have not received any similar complaints associated with the reported lot number.Root cause: as stated in the preceding section, we did not observe the attachment of blood clots to the filter media placed inside the returned filter; however, from the results of toluidine blue staining, it was confirmed in all the main membranes that staining was not uniform but uneven.Hence it was inferred that the inflow of non-uniform blood occurred in all the main membranes for some reason.In this case, it is presumed that blood is likely to be filtered faster than usual.From the investigation of the records relating to manufacturing and quality control, any abnormalities or deviations were not observed.We have not received any reports of the occurrence of the same issue against the lot number concerned; therefore, we inferred that the occurrence of this issue was limited and determined that the filter used this time met our quality standards.From the observation of the state of staining of the filter membranes which was performed this time, it was inferred that uneven blood inflow, which was different than usual, occurred in the filter; however, we were not able to identify the cause of the occurrence of this leukocyte reduction failure.Furthermore, from the investigation results and so forth of the past similar issues which our factory received, the following cases are cited as common causes of wbc count failures: - blood characteristics of a donor; and - white blood cells are leaked from the filter due to applying pressure to the collection bag or filter during filtering the collected blood.
 
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.Donor unit #: (b)(6).
 
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Brand Name
IMUFLEX BLOOD BAG SYSTEM
Type of Device
IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
Manufacturer (Section D)
TERUMO CORPORATION
fujinomiya
JA 
MDR Report Key12453851
MDR Text Key282980774
Report Number9681839-2021-00009
Device Sequence Number1
Product Code CAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/10/2021
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 No Information
Device Expiration Date08/31/2022
Device Catalogue Number1BBLGQ506A6
Device Lot Number210325AF
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/18/2021
Initial Date FDA Received09/10/2021
Supplement Dates Manufacturer Received09/16/2021
Supplement Dates FDA Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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