MalfunctionFII
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Received Dec 12, 2009 · Event occurred Sep 12, 2009
Report 1562059 · MDR key 1562059
Device
Generic name
Hemodialysis Machine, Continuous Renal Replacement Therapy
Manufacturer
Gambro Renal Products, IncModel number
PRISMAFLEXCatalog number
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Lot number
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Product problems
- Device Displays Incorrect Message
Patient
65 YR
- No Information
Narrative
Description of Event or Problem
DURING THE EVENING THE PRISMAFLEX CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE WENT DOWN WITH REPORTED ERROR OF "MALFUNCTION: BLOOD PUMP - INCORRECT RATE". FOLLOWING RETURN FROM CT, MACHINE HAD BEEN IN RECIRCULATING MODE. AN ATTEMPT WAS MADE TO REPRIME MACHINE AS DIRECTED BY MACHINE TO RESUME THERAPY, AT WHICH POINT ERROR OCCURRED, THUS REQUIRING THE SET UP OF AN ADDITIONAL CIRCUIT.