BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 3232115 · Received July 17, 2013

    Report

    Report Number
    9616026-2013-00003
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K083775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MACHINE MALFUNCTION WAS IDENTIFIED DURING THE TECHNICAL INVESTIGATION. ACCORDING TO THE ANALYZED LOGGING DATA, THE PRISMAFLEX MACHINE WORKED TO SPECIFICATION AND GENERATED APPROPRIATE ALARM CONDITIONS IN CONNECTION WITH THE REPORTED EVENTS. THE ANALYSIS SHOWED THAT THE ALARM "MALFUNCTION: GENERAL SYSTEM FAILURE (1)" WAS GENERATED AS THE OPERATOR TRIED TO MANUALLY ROTATE THE BLOOD PUMP WHEN THE PRISMAFLEX HAD ENTERED A PATIENT SAFE STATE (STOPPED BLOOD PUMP AND CLAMPED RETURN BLOOD LINE) DUE TO THE ALREADY TRIGGERED "WARNING: ACCESS EXTREMELY NEGATIVE". THE WARNING "ACCESS EXTREMELY NEGATIVE" WAS PROBABLY TRIGGERED BY A OBSTRUCTED CATHETER. GAMBRO HAS NO INFORMATION TO SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT AND GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    DURING THE COURSE OF 22 HOURS, A PATIENT UNDERGOING CVVHDF THERAPY HAD SUSTAINED A 517 ML BLOOD LOSS WHEN THE CONTENT OF TWO EXTRACORPOREAL CIRCUITS OF BLOOD WAS NOT RETURNED FOLLOWING A SERIES OF ACCESS RELATED ALARMS. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE BLOOD LOSS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331472 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB PRISMAFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other