TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
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Catalog Number 1BBWGQ506A2 |
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 07/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: we have not received the sets returned from the customer.We therefore performed investigation based on the provided information.In regard to the production of imuflex, 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.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.Only the filter media that have passed the standards are incorporated into the housing.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.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.Regarding the retained sample of the lot number concerned, three sets were visually inspected.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.We also 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 mentioned above, no abnormalities were observed in the manufacturing process or retained samples, and we were not able to identify the cause of the issue.Leukoreduction failures are commonly caused by the following factors: 1) analysis affected by blood properties of donors the following blood properties or blood conditions on blood collection may cause wbc count failures.For the details, please refer to the excerpt from the literature.Spurious counts and spurious results on wbc counts (spurious increase) platelet aggregates / large platelets nucleated red blood cells rbc resistant to lysis immunoglobulin lipids microorganisms / bacterial aggregates zandecki m, genevieve f, gerard j, godon a.Spurious counts and spurious results on haematology analyzers: a review.Part ii: white blood cells, red blood cells, hemoglobin, red cell indices and reticulocytes.International journal of laboratory hematology.2007, 29, 21¿41, table 1.2) pressure loaded on filter membranes 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", and ¿clamp the blood filled tubing before blood enters the filter¿.
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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 unit processing, therefore no patient information is reasonably known at the time of the event.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.3, h.6 and h.10.Investigation: we examined the sets concerned, which we received.In regard to the production of imuflex, 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.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.Only the filter media that have passed the standards are incorporated into the housing.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.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.Regarding the retained sample of the lot number concerned, three sets were visually inspected.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.We also 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.The filter of the set was rinsed with normal saline.The normal saline flowed through the filter at a flow rate of about 65 ml/min.No abnormalities were observed.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.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.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.We dyed the filter media with toluidine blue for observation.We noticed that the first and second filter membranes from the inlet side of the filter were dyed dark, that is, white blood cells were accumulated in these dark dyed areas.We also observed dark dyed areas in the first filter membrane from the inlet side of the filter due to minute aggregates.Corrected root cause: 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.Regarding the filters of the sets returned, the filter media in each filter were dyed dark, and the first filter membrane from the inlet side of each filter was dyed dark due to minute aggregates; therefore, occlusion caused by the aggregation of white blood cells or platelets may have occurred.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.
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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 unit processing, therefore no patient information is reasonably known at the time of the event.
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