MAUDE Adverse Event Report: TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-SP 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 02/26/2023

Event Type  malfunction  

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.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

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.In making leukoreduction filters, filter membranes are formed and put in filter housings.Review of the manufacturing record of the lot number in question was performed.There was no equipment trouble causing the issue concerned and it was confirmed that the equipment had operated properly, and no anomalies had been observed.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.Release testing, including a visual inspection and other items, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all 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.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.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.10.Investigation: we received one set of blood bags and evaluated the set.Investigation results of returned 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 3 ml/min.Following rinsing the filter with normal saline, we disassembled the filter and confirmed that abnormalities such as detached and misaligned filter media were not observed in the filter.The number of filter media in the filter conformed to the specifications.We also observed the appearance of filter media and confirmed aggregation in the eighth filter membrane from the inflow side of the filter.We dyed the rinsed filter media with toluidine blue to observe how white blood cells were trapped in the filter media.It was confirmed that the third through eighth filter membranes from the inflow side was 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.In making leukoreduction filters, filter membranes are formed and put in filter housings.Review of the manufacturing record of the lot number in question was performed.There was no equipment trouble causing the issue concerned and it was confirmed that the equipment had operated properly, and no anomalies had been observed.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.Release testing, including a visual inspection and other items, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all testing items.The product conformed to the standards.We used these sets of our retained samples of the lot concerned to measure the volume and concentration of the solution in the same manner as the release testing.The results conformed to our in-house standards.Corrected root cause: regarding the lot number concerned, there were no abnormalities in the manufacturing record, the inspection record, or the testing and inspection record.In addition, we did not observe any abnormalities in the retained samples of the lot number concerned.In the investigation of the filter of the set returned, normal saline flowed through the filter slowly, and the third through eighth filter membranes from the inflow side were 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.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP 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: 16611172
• MDR Text Key: 312317734
• Report Number: 9681839-2023-00018
• 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: 03/24/2023

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: 220617AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/23/2023
• 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