Model Number 82446 |
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 08/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: per the customer, they switched to a new apheresis platelet set at the beginning of the month when validating the trima software upgrade.Investigation is in process, a follow-up report will be provided.
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Event Description
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The customer reported that they had a positive bacterial detection.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.The disposable set is not available for return because it was discarded by the customer.
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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: per the customer, they switched to a new apheresis platelet set at the beginning of the month when validating the trima software upgrade.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.
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Event Description
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The customer reported that they had a positive bacterial detection.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.The disposable set is not available for return because it was discarded by the customer.
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Event Description
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The customer reported that they had a positive bacterial detection.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.The disposable set is not available for return because it was discarded by the customer.
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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: per the customer, they switched to a new apheresis platelet set at the beginning of the month when validating the trima software upgrade.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.* improper venipuncture technique and no blood diversion performed due to operator error resulting in bacterial contamination of product.* inadequate post-processing laboratory practices such as qc sampling or handling techniques.
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Search Alerts/Recalls
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