BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9555052 · Received January 6, 2020

    Report

    Report Number
    0001526350-2020-00021
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    October 19, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: JOW. 510(K) NUMBER: K101915 & K061814. PRODUCT REVIEW OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON OCTOBER 31, 2019 REVEALED THAT THE POWER CORD WAS DAMAGED AND THE WIRES WERE EXPOSED. REPAIR OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON OCTOBER 31, 2019 INCLUDED REPLACEMENT OF THE POWER CORD. VP500DM VASOPRESS PUMP, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT " THE DEVICE HAD A HOLE IN THE POWER CORD " WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE POWER CORD WAS DAMAGED AND WIRE WAS EXPOSED. A DEFINITIVE ROOT CAUSE OF THE DAMAGED POWER CORD COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE CAUSE FOR POWER CORD DAMAGE IS UNKNOWN. THE POWER CORD WAS REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS IS A WELL-KNOWN FAILURE MODE, WITH NO ALLEGATIONS OF HARM OR INJURY. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A HOLE IN THE POWER CORD. THERE WAS NO PATIENT IMPACT AND NOT AN OUT OF BOX FAILURE. THE EVENT OCCURRED DURING TESTING. THE INVESTIGATION IDENTIFIED THE PRESENCE OF EXPOSED WIRES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18989 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1