Catalog Number 1BBWGQ506A2 |
Device Problems
Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Filtration Problem (2941)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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 the unit processing,therefore no patient information is reasonably known at the time of the event.Terumo bct is awaiting return of the whole blood collection set for evaluation.
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Manufacturer Narrative
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Investigation: a set of red blood cell (rbc) storage bags with the filters was returned for investigation.The leukoreduction filter was tested for flow rate and air leaks.A slow flow rate of approximately 5ml/min was noted and it was confirmed there were no air leaks.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.All membranes conformed to established specification.There have been no other similar complaints against this production lot number.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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Event Description
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Unit #: (b)(6).
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Search Alerts/Recalls
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