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 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the set concerned has not yet been provided for evaluation.We therefore conducted investigations based on the provided information.In making the blood bags concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.In making leukoreduction filters, filter membranes are formed and put in filter housings.We reviewed the manufacturing record of the lot number in question.There was no equipment trouble causing the issue concerned and we confirmed that the equipment had operated properly, and no anomalies had been observed.We also reviewed the manufacturing records regarding particulate removal rates of filter membranes that were likely to be related to filtration performance.It was confirmed that all filter membranes conformed to all standards.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.We visually inspected three sets of our retained samples of the lot number concerned.There were no abnormalities in their appearances.We used these sets to measure the solution volume and also to perform the quantitative test for the composition of the solution in the same manner as the release testing.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: blood characteristics of donors there is a possibility of leukoreduction failure due to blood characteristics of donors.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.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.Donor unit id: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Corrected information is provided in h.10.Updated investigation: we received the collection bag connected to the leukocyte reduction filter with bypass line for evaluation.We injected 570 ml of normal saline into the collection bag and observed a slow flow rate of normal saline through the filter, which was at 11ml/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 that there were no aggregates adhered to the filter media.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 first filter membrane from the inflow side was dyed dark with toluidine blue.Investigation: in making the blood bags concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.In making leukoreduction filters, filter membranes are formed and put in filter housings.We reviewed the manufacturing record of the lot number in question.There was no equipment trouble causing the issue concerned and we confirmed that the equipment had operated properly, and no anomalies had been observed.We also reviewed the manufacturing records regarding particulate removal rates of filter membranes that were likely to be related to filtration performance.It was confirmed that all filter membranes conformed to all standards.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.We visually inspected three sets of our retained samples of the lot number concerned.There were no abnormalities in their appearances.We used these sets to measure the solution volume and also to perform the quantitative test for the composition of the solution in the same manner as the release testing.The results conformed to our in-house standards.Corrected root cause: in the investigation of the filter of the set returned, normal saline flowed through the filter slowly, and the first filter membrane 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.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.Donor unit id: (b)(6).

• 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: 16398014
• MDR Text Key: 309895011
• Report Number: 9681839-2023-00009
• 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: 02/17/2023

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: 220616AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/14/2023
• 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