Catalog Number 1BBWGQ506A2 |
Device Problems
High Test Results (2457); Filtration Problem (2941)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) is submitting this report on behalf of (b)(4) of terumocorp., (manufacturer).(b)(4).Investigation is in process a follow-up report will be provided.
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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 there was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event donor unit #: (b)(4) 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 whole blood collection set was not available for return for evaluation.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.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 productbag) could have contributed to the higher-than-expected wbc content in the whole bloodproduct.The instructions for use provide a caution to not squeeze or apply pressure to the filter while it isattached to the bag containing the filtered blood and to not clamp the blood filled tubing beforethe blood enters the filter in order to avoid leukocyte leakage.
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Search Alerts/Recalls
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