BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 2181921 · Received November 22, 2006

    Report

    Report Number
    9616240-2006-00478
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    October 26, 2006
    Report Date
    October 26, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    PMA / PMN Number
    K010805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINED STABLE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION NOR WAS ANY INJURY SUSTAINED. THIS WAS A (B)(6) FEMALE PATIENT STATUS POST CARDIAC ARREST. THE TREATMENT HAD BEEN INITIATED ON (B)(6) 2006. THE TREATMENT MODALITY WAS CONTINUOUS VENO-VENUS HEMODIAFILTRATION (CVVHDF). THE PATIENT WAS BEING MAINTAINED WITH MECHANICAL VENTILATION. THE PATIENT WAS ON NO INOTROPIC MEDICATIONS. NO OTHER PATIENT INFORMATION WAS PROVIDED. AT THE REQUEST OF THE FACILITY'S NURSE, FACILITY'S REGISTERED NURSE, SURGICAL INTENSIVE CARE UNIT (SICU) EDUCATOR INSPECTED THE MACHINE. SHE MADE SURE THERE WERE NO CLAMPS, WHAT SHE DID NOTE WAS THAT THE FRANGIBLE PIN, WHICH HAD BEEN BROKEN, SEEMED TO PARTIALLY OCCLUDE THE ADMINISTRATION LINE. AFTER READJUSTING THE BAG, THE PATIENT'S FLUID REMOVAL WAS INCREASED BACK TO 200 ML/HR. THERE WERE NO FURTHER FLUID REMOVAL ISSUES. DURING THIS TIME THE PATIENT'S VITAL SIGNS REMAINED STABLE. NO EXTRA IV FLUID WAS REQUIRED. THE MACHINE WAS NOT INVESTIGATED AS THE TREATMENT WAS CONTINUED UTILIZING THE SAME MACHINE WITH NO FURTHER FLUID REMOVAL ISSUES. SOLUTION BAG MANUFACTURER REPORT # 1051129-2006-00012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PRISMA MACHINE REMOVED TOO MUCH FLUID DURING A PATIENT'S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION. IT WAS NOTED AT 1 PM THAT THERE WAS AN EXTRA 215 ML OF FLUID REMOVED FROM THE PATIENT. THIS WOULD CORRESPOND TO THE DECREASE RECORDED ON THE DIALYSATE FLUID. AT 1:15 PM, IT WAS NOTED THAT THE PATIENT'S FLUID REMOVAL WAS ALREADY 150 ML. THE NURSE DECREASED THE PATIENT'S FLUID REMOVAL RATE TO ZERO. THE ONLY ALARM REPORTED WAS THE PERIODIC SELF-TEST FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS KDI GAMBRO DASCO PRISMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other