MAUDE Adverse Event Report: TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP 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 04/10/2023

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.Donor unit #: (b)(6) there was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Investigation: we examined the set concerned which we received.The filter of the set was rinsed with normal saline.The normal saline flowed through the filter at a fast flow rate of more than 100 ml/min.An airtightness test (i.E.Leak test) was performed on the filter in accordance with the following procedures and we confirmed that air leaks were not observed in any locations of the filter.I) the tab sheet covering the outlet side (second side) of the filter is cut out carefully and exposed the outlet side to allow observing the frame sheet (partition) directly.Ii) air is admitted to the filter, which is submerged in water, from the outlet-tube of the filter at a gauge pressure of 39.2 kpa (0.4 kgf/cm2) for approximately 10 seconds to check whether there is any air leakage from the frame sheet (partition).We disassembled the rinsed filter to observe the appearance of filter media (membranes).We noticed creases in the filter media; however, the creases were not different from those observed in conforming products.We did not observe aggregates adhered to the filter media.After passing normal saline through the filter, we dyed the filter media with toluidine blue for observation.We noticed that the fifth and six filter membranes from the inlet side of the filter were dyed dark, that is, white blood cells were accumulated in these dark dyed areas.With regard to three sets of the retained samples of the lot number concerned, we measured the volume and concentration of the solution in the same manner as the release testing.We did not see any abnormalities, and the results conformed to our in-house standards.Root cause: as the investigation results provided in our initial answer card, no abnormalities were observed in the manufacturing record or the testing and inspection record of the lot number concerned.We also investigated the retained samples of the lot number concerned, and the results revealed no abnormalities.In the investigation of the filter of the set returned, the fifth and sixth filter membranes from the inflow side was entirely dyed dark with toluidine blue; therefore, occlusion may have occurred in the filter.Blood may have been filtered by the filter area which was smaller than usual, and the linear speed (flow rate per unit area) increased and consequently leukocyte leakage occurred.In this case, the extension of filtration time is likely to occur concurrently.From the similar incidents which were previously reported, it was inferred the clogged components were aggregated platelets.We consider that platelets, which activated and aggregated for some reason, were trapped by the filter.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit #: (b)(6).There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the 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 FACTORY OF TERUMO CORP; 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: 16962971
• MDR Text Key: 316434252
• Report Number: 9681839-2023-00033
• 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: 05/18/2023

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: 1BBWGQ506A2
• Device Lot Number: 220921AF
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 05/29/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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