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 1BBLGQ506A6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/05/2023

Event Type  malfunction  

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 unit processing, 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: the set concerned was not available and we therefore conducted the following investigations based on the information provided.Upon making the blood bag concerned, 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.The manufacturing records regarding particulate removal rates of filter membranes that were likely to be related to filtration performance were reviewed.It was confirmed that all filter membranes conformed to all standards.Review of the manufacturing record of the lot number in question was performed.There was no equipment trouble causing the issue concerned and we confirmed that the equipment had operated properly, and no anomalies had been observed.Release testing, which includes 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 release testing items.The product conformed to the standards.Three sets of retained samples of the lot number concerned were visually inspected.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.We also measured the volume and concentration of the solution of the retained samples 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: from the above-mentioned investigation results, we did not observe any abnormalities in the manufacturing process of the lot number concerned.As mentioned in the investigation results above, the filter membranes of the product concerned consist of a rough-pore pre-membrane (the first filter membrane) and minute-pore main membranes (the second through eighth filter membranes).According to the data at the time of designing of the product in question, there is a possibility of white blood cell contamination when the particulate removal rates are low.However, as mentioned above, the particulate removal rates of the lot number concerned were within the standards and did not show a low tendency.Therefore, we were not able to identify the cause of the issue.Leukoreduction failure is commonly caused by the following factors: 1) blood characteristics of donors there is a possibility of leukoreduction failure due to blood characteristics of donors.2) pressure loaded on filter membranes for some reason, where a physical stress on filter membranes is greater than what is expected, trapped white blood cells are pushed out of the filter membranes and may result in leukoreduction failure.For the prevention of leukoreduction failure, the instructions for use (ifu) of the product state: "[caution] do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood".Based on the investigation results of similar issues which we received in the past, a general cause of leukocyte reduction failure can be cited that pressure was applied to the collection bag or the filter during the filtration process of the collected blood.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.9, h.3, h.6 and h.10.Corrected information is provided in h.10.Investigation: we conducted the following investigation on the set.We injected 570 ml of normal saline into the collection bag and observed a slow flow through the filter.The flow rate of normal saline was about 10 ml/min.Following rinsing the filter with normal saline, we disassembled the filter and confirmed that abnormalities such as detached and misaligned filter membranes were not observed in the filter.The number of filter membranes in the filter conformed to the specifications.The lower part of each filter membrane was not soaked with blood, and it was inferred that the air was remained in the lower part of the filter.We dyed the rinsed filter membranes with toluidine blue to observe how white blood cells were trapped in the filter membranes.It was confirmed that the first through fourth filter membranes from the inflow side were dyed dark with toluidine blue.Upon making the blood bag concerned, 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.The manufacturing records regarding particulate removal rates of filter membranes that were likely to be related to filtration performance were reviewed.It was confirmed that all filter membranes conformed to all standards.Review of the manufacturing record of the lot number in question was performed.There was no equipment trouble causing the issue concerned and we confirmed that the equipment had operated properly, and no anomalies had been observed.Release testing, which includes 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 release testing items.The product conformed to the standards.Three sets of retained samples of the lot number concerned were visually inspected.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.We also measured the volume and concentration of the solution of the retained samples in the same manner as the release testing.We did not see any abnormalities, and the results conformed to our in-house standards.Corrected 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, normal saline flowed slowly through the filter, and the second and third filter membranes from the inflow side were entirely dyed dark with toluidine blue; therefore, occlusion may have occurred in the filter.When occlusion occurs in the filter, blood may be filtered by the filter area which is smaller than usual, and pressured is applied to the filter media then leukocyte leakage may occur.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit #: (b)(4) 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.

• 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: 17042011
• MDR Text Key: 317637976
• Report Number: 9681839-2023-00040
• 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: 06/01/2023

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 220603AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/21/2023
• 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