BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 1691378 · Received April 30, 2010

    Report

    Report Number
    9616240-2010-00006
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 1, 2010
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    PMA / PMN Number
    K070643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED GAMBRO'S REQUEST TO HAVE THE MACHINE INSPECTED BY A GAMBRO TECHNICAL SERVICE REPREHENSIVE. THE MACHINE CONTINUED TO BE USED ON OTHER PTS WITHOUT PROBLEMS OBSERVED. FIVE DAYS AFTER THE EVENT, FOLLOWING AN UNRELATED ISSUE ON THE SAME MACHINE, THE CUSTOMER REQUIRED AN INSPECTION BY A GAMBRO TECHNICIAN. THE TECHNICIAN DETERMINED THE PH PROBE WAS NOT FUNCTIONING AND THE PROBE WAS REPLACED, OTHERWISE THE MACHINE WAS OPERATING WITHIN MFR'S SPECIFICATION. THE MACHINE IS CURRENTLY IN USE. NO FURTHER ISSUES HAVE BEEN REPORTED TO GAMBRO.

    Description of Event or Problem · 1

    DURING THE DIALYSIS TREATMENT THE PT COMPLAINED OF "FEELING FUNNY" AND SHORTNESS OF BREATH. THE PT WAS ADMINISTERED 2L OF OXYGEN PER NASAL CANNULA. HER BLOOD PRESSURE WAS INCREASED TO 223/124 MMHG. SHE WAS BRIEFLY DISCONNECTED FROM TREATMENT TO GO TO THE BATHROOM. FOLLOWING THE DIALYSIS TREATMENT THE PT WAS DISCHARGED HOME. SEVERAL HOURS LATER, THE PT WAS ADMITTED TO THE HOSPITAL'S ICU WITH THE DIAGNOSIS OF HEMOLYSIS. WHILE HOSPITALIZED SHE RECEIVED A TRANSFUSION OF ONE UNIT OF BLOOD. HER CONDITIO RAPIDLY IMPROVED FOLLOWING THE TRANSFUSION. SHE WAS DISCHARGED FROM THE HOSPITAL AND HAS TRANSFERRED TO ANOTHER OUTPATIENT DIALYSIS UNIT. THE MEDICAL INFO PROVIDED IS LIMITED AND THE ONLY LAB INFO INDICATES THE PT HAD A DROP IN HGB, INCREASED BILIRUBIN LEVEL AND ELEVATED POTASSIUM LEVEL. THE MEDICAL DIRECTOR OF THE UNIT HAD NO ADDITIONAL INFO TO PROVIDE. THE CAUSE OF THE HEMOLYSIS IS NOT KNOWN. THE NURSE REPORTED THAT NO KINKS WERE OBSERVED IN THE TUBING, AND NO UNUSUAL NOISES WERE HEARD FROM THE BLOOD PUMP. THE DIALYZER AND BLOOD TUBING SET HAVE BEEN DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    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 39 YR Hospitalization