Catalog Number 1BBWGQ506A2 |
Device Problems
High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) is submitting this report on behalf of fujinomiya factory of terumocorp., (manufacturer).Exemption number: (b)(4).Investigation in progress.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) count in the whole blood unit.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 id: w121016004830terumo corp is awaiting the return of the device.
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Manufacturer Narrative
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Investigation is still in process.A follow-up report will be provided.
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Event Description
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The whole blood collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: the collection set was not available for return for evaluation.The manufacturing and testing records were reviewed for this lot number.No abnormalities were noted in the records that would have contributed to the issue.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be donor-related(characteristics of blood).It also cannot be ruled out that a filtering error or other process error(not resting the collected blood prior to filtering; not expressing air properly from the product bag) could have contributed to the higher-than-expected wbc content in the whole blood product.The instructions for use provide a caution to not squeeze or apply pressure to the filter while it is attached to the bag containing the filtered blood in order to avoid leukocyte leakage.
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Search Alerts/Recalls
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