BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 9340287 · Received November 19, 2019

    Report

    Report Number
    0001526350-2019-01030
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: JOW. PMA/510(K) NUMBER - K101915 & K061814. PRODUCT REVIEW OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON AUGUST 29, 2019 REVEALED THAT THE BATTERY PACK WAS DAMAGED AND HAD ELECTRICAL ISSUES AND THE POWER CORD WAS CUT. PER THE VERBAL COMMUNICATION WITH THE TECHNICIAN THE POWER CORD WIRES WERE EXPOSED. REPAIR OF THE VP500DM VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON AUGUST 29, 2019 INCLUDED REPLACEMENT OF BATTERY AND 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 BATTERY NOT CHARGING" WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE BATTERY PACK WAS DAMAGED AND HAD ELECTRICAL ISSUES. THE REPORTED EVENT "THE DEVICE HAD HOLE IN THE CORD" WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE POWER CORD WAS CUT. PER THE VERBAL COMMUNICATION WITH THE TECHNICIAN THE POWER CORD WIRES WERE EXPOSED. A DEFINITIVE ROOT CAUSE OF THE BATTERY NOT CHARGING COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE CAUSE FOR BATTERY DAMAGE IS UNKNOWN. A DEFINITIVE ROOT CAUSE OF HOLE IN THE CORD COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN HAT CAUSED THE DAMAGE TO THE POWER CORD. 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. 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 PRODUCT WAS RETURNED WITH NO ADDITIONAL DETAIL. UPON REPAIR OF THE PRODUCT, IT WAS REPORTED THAT THE UNIT BATTERY NOT CHARGING, AND THERE WAS A HOLE IN THE CORD AS WELL. IT WAS CONFIRMED BY THE REPAIR TECHNICIAN THAT THERE WERE EXPOSED WIRES. THERE WAS NO PATIENT IMPACT, AND THIS WAS NOT AN OUT OF BOX FAILURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140131 VASOPRESS DIGITAL MINI PUMP SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1