TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
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Catalog Number 1BBLGQ506A6 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 one of the sets to measure the solution volume in the same manner as the release testing.The result 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.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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Investigation: we received one complete blood bag set for investigation.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 13 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 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 second filter membrane from the inflow side was dyed dark with toluidine blue.We also confirmed that all the filter media facing the correct direction were placed in the filter assembly.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 one of the sets to measure the solution volume in the same manner as the release testing.The result 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 second 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.
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