BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6813958 · Received August 23, 2017

    Report

    Report Number
    3003477173-2017-00005
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 23, 2017
    Manufacturer
    ADVANCED CIRCULATORY SYSTEMS
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REMOVING THE RESQPUMP FROM THE BOX, THE PUMP WAS IN GOOD CONDITION WITH NO SIGNS OF DAMAGE. THE FORCE GAUGE WAS ZEROED WHEN FIRST REMOVED FROM THE BOX. WHEN THE PUMP WAS COMPRESSED FOR THE FIRST TIME, IT GOT STUCK AT 50 KG. AFTER TAKING THE CLAMSHELL APART, THE GAUGE MECHANISM VISUALLY LOOKED TO BE IN WORKING ORDER (SPRING AND GAUGE IN CORRECT ORIENTATION). THE PUSHROD STEM COULD BE PULLED OUT BUT WAS DIFFICULT TO DO THE FIRST TIME. A BLACK SPOT WAS IDENTIFIED ON STEM THAT WAS POTENTIALLY EXCESS LOCTITE BUT IT WASN'T CONFIRMED. WHEN THE PUMP WAS REASSEMBLED, THE GAUGE WORKED SMOOTHLY AND NO OTHER PROBLEMS WERE DETECTED. THE ACCURACY OF THE FORCE GAUGE WAS VERIFIED ON A SCALE AND ARE WITHIN SPECIFICATION. THE INVESTIGATION SUGGESTS THAT AN EXCESSIVE AMOUNT OF LOCTITE WAS PUT ON THE STEM CAUSING IT TO STICK IN PLACE. THIS CAUSED THE FORCE GAUGE TO GET STUCK AT 50 KG AFTER BEING COMPRESSED.

    Description of Event or Problem · 1

    UNWRAPPED THE RESQPUMPS STRAIGHT FROM THE BOX. THE FORCE GAUGE ON ONE OF THE PUMPS WAS STUCK AT 50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593426 RESQPUMP RESQPUMP PIZ ADVANCED CIRCULATORY SYSTEMS 12-0823-000 51733641

    Patients

    Seq Age Sex Outcome Treatment
    1