BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1513538 · Received July 23, 2009

    Report

    Report Number
    9616240-2009-00001
    Event Type
    Other
    Date Received
    July 23, 2009
    Date of Event
    December 4, 2008
    Report Date
    December 19, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    PMA / PMN Number
    K001156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GAMBRO TECHNICAL SERVICES REP INSPECTED THE MACHINE AND CONCLUDED THAT IT WAS OPERATING WITHIN MFR'S SPECIFICATION. THE BLOOD TUBING SET AND OTHER DISPOSABLES WERE DISCARDED AND THEREFORE, UNABLE TO BE RETURNED FOR ANALYSIS. BASED ON THE EVALUATIONS OF THE CLINICAL INFO AND THE RESULTS OF THE TECHNICAL INVESTIGATION, IT IS BELIEVED THAT THE LOW HAPTOGLOBIN LEVELS ARE MORE LIKELY A REFLECTION OF THE PT'S OVERALL MEDICAL STATUS. THERE IS NO EVIDENCE THAT SUGGESTS A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 1

    EIGHT MINUTES INTO A ROUTINE HD TREATMENT ON A PHOENIX MACHINE, THE ARTERIAL PRESSURE WENT FROM -100 TO 0, THE PT WAS HYPOTENSIVE AND NAUSEATED. THE NURSE RETURNED THE PT'S BLOOD AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION FOR THE HYPOTENSION OR NAUSEA. THE PT CONTINUED HD TREATMENT ON ANOTHER PHOENIX MACHINE WITHOUT FURTHER INCIDENT. FOLLOWING COMPLETION OF THE HD TREATMENT, THE PT WAS DISCHARGED HOME IN STABLE CONDITION. THE PHYSICIAN ORDERED A BLOOD SPECIMEN FOR HAPTOGLOBIN AND FREE HEMOGLOBIN TO ASSESS ANY POSSIBLE HEMOLYTIC EVENT. THE LAB REPORTED HAPTOGLOBIN <10 MM/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT KDI GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other