BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 1677996 · Received May 6, 2010

    Report

    Report Number
    9616026-2010-00005
    Event Type
    Injury
    Date Received
    May 6, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K072093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO TECHNICAL SERVICE REP INSPECTED THE PRISMAFLEX MACHINE. HE COULD NOT REPRODUCE THE PROBLEMS REPORTED AND FOUND THE PRISMAFLEX TO BE OPERATING ACCORDING TO THE MFR'S SPECIFICATION. THE PRISMAFLEX WAS RETURNED TO SERVICE. THE FROZEN SCREEN ISSUE IS ADDRESSED IN THE NEXT SOFTWARE RELEASE IN 510 (K) K083775, (B) (6).

    Description of Event or Problem · 1

    TREATMENT ON A PRISMAFLEX MACHINE WAS TERMINATED, THE TOUCH SCREEN WAS NOT RESPONSIVE AND THE RINSE BACK WAS TERMINATED WITHOUT RETURNING THE BLOOD TO THE PT. TREATMENT WAS RESTARTED WITH A NEW FILTER WHEN THE NURSE REALIZED SHE SET UP THE WRONG FILTER. RINSE BACK WAS ATTEMPTED BUT ONCE AGAIN THE TOUCH SCREEN WAS NOT RESPONSIVE AND THE BLOOD WAS NOT RETURNED TO THE PT RESULTING IN A BLOOD LOSS OF APPROXIMATELY 258 ML. THE PT'S OVERALL MEDICAL STATUS DID NOT CHANGE AS A RESULT OF THE BLOOD LOSS BUT THE HEMOGLOBIN DROPPED AND THE PHYSICIAN ORDERED A TRANSFUSION OF PACKED RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX INTENSIVE CARE HEMODIALYSIS KDI GAMBRO LUNDIA AB 107493

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention