BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6678700 · Received June 29, 2017

    Report

    Report Number
    3003477173-2017-00003
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    May 25, 2017
    Report Date
    June 29, 2017
    Manufacturer
    ADVANCED CIRCULATORY
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP CAME TO ACSI WITH THE FORCE GAUGE READING AT 0 KG. THE GAUGE WORKED AS EXPECTED FOR A FEW COMPRESSIONS THEN STUCK AT 30 KG MOMENTARILY, THEN RELEASED AND RETURNED TO 0. NOTHING EXTERNAL OR INTERNAL INDICATED THAT THERE WERE ANY MODIFICATIONS OR MISUSE OF THE DEVICE. THE PUSHROD ASSEMBLY WAS NOT STUCK IN THE TRANSFER SPRING, HOWEVER WHEN REMOVING IT WAS SOMEWHAT ROUGH, ESPECIALLY THE LAST THIRD OF THE PUSHROD. THE PUSHROD LOOSENED UP AFTER SOME MANIPULATION. THE COMPONENTS WERE REASSEMBLED AND THE FORCE GAUGE RETURNED TO ZERO. THE FORCE GAUGE WORKED SMOOTHLY AND DID NOT GET HUNG UP AGAIN AFTER SEVERAL COMPRESSIONS. THE FORCE GAUGE WAS VERIFIED ON A SCALE (FORCE GAUGE KG/SCALE KG; -15/-14, 50/48) ALL WITHIN SPECIFICATION. THE GAUGE RETURNED TO ZERO AFTER EACH COMPRESSION/DECOMPRESSION. IT IS THOUGHT THAT EXCESS LOCTITE WAS ON THE PUSHROD STEM. WHEN THE PUMP WAS COMPRESSED THE PUSHROD MUST HAVE GOTTEN STUCK IN THE UP POSITION CAUSING THE GAUGE TO READ HIGH AND NOT RETURN TO ZERO FOR A TIME.

    Description of Event or Problem · 1

    OUT OF BOX FAILURE. NO PATIENT INVOLVEMENT. FORCE GAUGE NOT IN CALIBRATION AND STUCK IN COMPRESSION MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458774 RESQPUMP RESQPUMP PIZ ADVANCED CIRCULATORY 12-0823-000 51733641

    Patients

    Seq Age Sex Outcome Treatment
    1