BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M150 SET

    MDR report key: 4080797 · Received September 5, 2014

    Report

    Report Number
    MW5038112
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    GAMBRO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, AT APPROXIMATELY 1100, THE PRISMAFLEX PUMP #2 HAD A "GENERAL SYSTEM MALFUNCTION" ALARM. THE PUMP SHUT DOWN AUTOMATICALLY AND THE ONLY OPTION TO RETURN BLOOD WOULD BE TO DO SO AUTOMATICALLY USING THE CRANK. STAFF WERE TOO CONCERNED ABOUT CLOT FORMATION AND THEREFORE CHOSE NOT TO RETURN THE BLOOD. ON (B)(6) 2014, AT 0600, PATIENT RECEIVED ONE UNIT OF PRBC'S. THIS PUMP WAS REMOVED FROM SERVICE ON (B)(6) 2014 AND EVALUATED IN CLINICAL ENGINEERING DEPARTMENT. PUMP #2 WAS RETURNED FOR CLINICAL USE ON (B)(6) 2014. SPECIFIC FINDINGS OF EVALUATION UNKNOWN. PRISMAFLEX PUMP #2; SN (B)(4); STAFF REPORT THAT THE PRISMAFLEX M150 SET IS NOT LOADING PROPERLY REQUIRING STAFF TO RE-LOAD MULTIPLE TIMES. WHEN STILL UNSUCCESSFUL, STAFF WILL OBTAIN A NEW FILTER SET AND TRY AGAIN. IT APPEARS THAT THE TUBING IS NOT LOADING ALL THE WAY BACK ON THE LOWER RIGHT PUMP. THIS HAS BEEN EXAMINED BY CLINICAL ENGINEERING MULTIPLE TIMES WITHOUT AN ERROR MESSAGE APPEARING. IT WAS SUGGESTED THAT IF STAFF NUDGE THE FILTER SET DOWN AND TO THE RIGHT BY HOLDING ONTO THE VERTICAL FILTER, THAT THIS MAY IMPROVE THE ABILITY OF THE LOWER RIGHT SIDE PUMP TO SEAT THE TUBING CORRECTLY ON THE PUMP HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543263 PRISMAFLEX M150 SET TUBING FPA GAMBRO M150 13K2903G
    543264 PRISMAFLEX PUMP PUMP FRN GAMBRO

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR