Catalog Number 1BBLGQ506A6 |
Device Problems
Contamination of Device Ingredient or Reagent (2901); 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 10/05/2022 |
Event Type
malfunction
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Event Description
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The customer reported an elevated white blood cell content in the whole blood product.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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Investigation is in process.A follow up report will be provided.
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Event Description
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The customer reported an elevated white blood cell (wbc) content in the whole blood product.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 additional information in h.6 and h.10.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.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.
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Event Description
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The customer reported an elevated white blood cell (wbc) content in the whole blood product.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.Donor unit #: (b)(6).
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Manufacturer Narrative
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This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: we received the primary bag (red blood cell storage bag) and the satellite bag (platelet storage bag).The leukocyte reduction filter was not returned and we were not able to investigate the filter, which is related to filtration function.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.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.
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Search Alerts/Recalls
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