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TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
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Back to Search Results |
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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 02/18/2024 |
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Event Type
malfunction
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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 id # (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 collection set for evaluation.
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Manufacturer Narrative
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Investigation: we have not yet received the set concerned for evaluation.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 leukoreduction 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.Root cause: as mentioned above, abnormalities were not observed in the manufacturing process or the retained samples of the lot number concerned; therefore, we were not able to identify the cause of the multiple occurrences 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, 2141, 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.3) filter occlusion caused by aggregation of blood components in the filter concerned, when aggregation caused by blood components such as white blood cells or platelets, there is a possibility of filter media clogging.When clogging occurs in the filter, blood may be filtered by the filter area which is smaller than usual, and the linear speed (flow rate per unit area) accelerates, and then a leukoreduction failure may occur.For the prevention of formation of blood aggregation, please invert the collection bag several times as soon as possible after blood collection to ensure that the blood and anticoagulant are well-mixed as well as before filtration to evenly disperse the separated blood components.
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Manufacturer Narrative
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Investigation: we received one set of the leukocyte reduction filter and the collection bag (unit no.(b)(6)), and performed the following investigations.We observed the set and found blood clotting in the cliktip of the collection bag.The filter was rinsed with normal saline.The normal saline slowly flowed through the filter at a flow rate of about 18 ml/min.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.(i) 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.(ii) 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.Blood aggregates were observed in the second filter membrane from the inlet side of the filter.We dyed the filter media with toluidine blue for observation.We noticed that the first, fifth, and sixth 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 that the first filter membrane from the inlet side of the filter was dyed dark due to minute aggregates.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 leukoreduction 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.Root cause: as mentioned above, abnormalities were not observed in the manufacturing process or the retained samples of the lot number concerned; therefore, we were not able to identify the cause of the multiple occurrences 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¿.3) filter occlusion caused by aggregation of blood components in the filter concerned, when aggregation caused by blood components such as white blood cells or platelets, there is a possibility of filter media clogging.When clogging occurs in the filter, blood may be filtered by the filter area which is smaller than usual, and the linear speed (flow rate per unit area) accelerates, and then a leukoreduction failure may occur.For the prevention of formation of blood aggregation, please invert the collection bag several times as soon as possible after blood collection to ensure that the blood and anticoagulant are well-mixed as well as before filtration to evenly disperse the separated blood components.In the investigations stated above, the blood aggregation was present in the cliktip of the collection bag, and we observed the first filter membrane from the inlet side of the filter was dyed dark due to minute aggregates, and the first, fifth, and sixth filter membranes were entirely dyed dark; therefore, occlusion caused by the aggregation of white blood cells or platelets may have occurred.When the filter media occluded, 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.For the lot number concerned, we did not observe any abnormalities in the manufacturing record, testing and inspection record, or retained samples; therefore, we were not able to identify the cause of the issue.
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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 id # (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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Event Description
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The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit id # (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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Manufacturer Narrative
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This report is being filed to provide corrected information in h.11.Investigation: we received one set of the leukocyte reduction filter and the collection bag (unit no.(b)(6)and performed the following investigations.We observed the set and found blood clotting in the cliktip of the collection bag.The filter was rinsed with normal saline.The normal saline slowly flowed through the filter at a flow rate of about 18 ml/min.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.(i) 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.(ii) 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 dyed the filter media with toluidine blue for observation.We noticed that the first, fifth, and sixth 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 that the first filter membrane from the inlet side of the filter was dyed dark due to minute aggregates.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 leukoreduction 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.Root cause: as mentioned above, abnormalities were not observed in the manufacturing process or the retained samples of the lot number concerned; therefore, we were not able to identify the cause of the multiple occurrences 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¿.3) filter occlusion caused by aggregation of blood components in the filter concerned, when aggregation caused by blood components such as white blood cells or platelets, there is a possibility of filter media clogging.When clogging occurs in the filter, blood may be filtered by the filter area which is smaller than usual, and the linear speed (flow rate per unit area) accelerates, and then a leukoreduction failure may occur.For the prevention of formation of blood aggregation, please invert the collection bag several times as soon as possible after blood collection to ensure that the blood and anticoagulant are well-mixed as well as before filtration to evenly disperse the separated blood components.In the investigations stated above, the blood aggregation was present in the cliktip of the collection bag, and we observed the first filter membrane from the inlet side of the filter was dyed dark due to minute aggregates, and the first, fifth, and sixth filter membranes were entirely dyed dark; therefore, occlusion caused by the aggregation of white blood cells or platelets may have occurred.When the filter media occluded, 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.For the lot number concerned, we did not observe any abnormalities in the manufacturing record, testing and inspection record, or retained samples; therefore, we were not able to identify the cause of the issue.
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