BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 978677 · Received April 6, 2007

    Report

    Report Number
    2087532-2007-00085
    Event Type
    Other
    Date Received
    April 6, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 8, 2007
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE INCIDENT OF A PRISMA MACHINE, SOFTWARE VERSION 3.10 GOING INTO PRIME TEST TWICE AND SHOWING MULTIPLE PRIME SCREENS. FACILITY'S NURSE MGR WAS UNAWARE AT THE TIME OF THIS INCIDENT THAT THE PROMPTS ON THE PRIME SCREEN HAD CHANGED WITH THE SOFTWARE UPGRADE FROM 2.51 TO 3.10 . FACILITY 'S INTENSIVE CARE (IC) NURSE WAS SETTING UP A PRIMSA MACHINE TO USE ON A PT. THE NURSE FOLLOWED THE HOSPITAL'S POLICY FOR THE 2.15 SOFTWARE REGARDING PRIMING THE MACHINE AND WHEN THE MACHINE FINISHED PRIMING, IT WENT INTO ITS NORMAL PRIME TEST, WHICH IT PASSED. THEN THE NURSE MANUALLY PRIMED THE MACHINE WITH THE PT'S OWN BLOOD AND WHEN SHE WAS FINISHING DOING THAT, SHE THOUGHT THE MACHINE WENT INTO PRIME TEST AGAIN. WHILE THE MACHINE WAS IN ITS SECOND PRIME TEST, THE NURSE HOOKED THE PT UP TO THE PRIMSA MACHINE. WHILE IN ITS PRIME TEST, THE PT'S CENTRAL LINE "BLEW UP" WHERE IT CONNECTED TO THE PT. THE NURSE WAS ABLE TO STOP THE BLEEDING ON THE PT AND THEN RESTARTED THE SET-UP.

    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 UNKNOWN Other