BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESQPUMP

    MDR report key: 6609818 · Received June 2, 2017

    Report

    Report Number
    3003477173-2017-00002
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 8, 2017
    Report Date
    June 2, 2017
    Manufacturer
    ADVANCED CIRCULATORY SYSTEMS
    Product Code
    PIZ
    PMA / PMN Number
    P110024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP ARRIVED AT ACSI WITH THE FORCE GAUGE READING AT 40 KG. THE GAUGE WOULD NOT MOVE DURING ATTEMPTING TO COMPRESS OR DECOMPRESS THE PUMP. NOTHING EXTERNAL OR INTERNAL INDICATED THAT THERE WERE ANY MODIFICATIONS OR MISUSE OF THE DEVICE. THE PUSHROD ASSEMBLY WAS STUCK IN THE TRANSFER SPRING. IT TOOK A GOOD AMOUNT OF FORCE TO MANUALLY REMOVE THE PUSHROD. THE PUSHROD LOOSENED UP AFTER SOME MANIPULATION. THE COMPONENTS WERE REASSEMBLED AND THE FORCE GAUGE RETURNED TO ZERO. THE FORCE GAUGE WAS VERIFIED ON A SCALE (FORCE GAUGE KG/SCALE KG; -15/-14, 50/54) 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.

    Description of Event or Problem · 1

    THE RESQPUMP FORCE GAUGE WAS REPORTED STUCK IN THE COMPRESSION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388900 RESQPUMP RESQPUMP PIZ ADVANCED CIRCULATORY SYSTEMS 12-0823-000

    Patients

    Seq Age Sex Outcome Treatment
    1