Catalog Number 5000-01-01 |
Device Problems
Short Fill (1575); Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that the arctic sun did not fill the pads.
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Event Description
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It was reported that the arctic sun did not fill the pads.
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Manufacturer Narrative
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The reported issue was confirmed by crs.The root cause of the reported issue was isolated to a faulty circulation pump.During calibration the unit displayed an error 80.The field technician could not complete the evaluation and the unit had to be returned to the crs depot.The unit was received at the crs depot on 02.27.19.Upon further evaluation it was noted the mixing pump was also bad, which would have caused the error 80.No repairs to date as there was a quotation discrepancy.This record will be closed until the cost of repair is decided upon and the unit is repaired.At that time the record will be reopened and updated accordingly.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following:
¿the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿.
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Search Alerts/Recalls
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