BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS PUMP

    MDR report key: 9129736 · Received September 27, 2019

    Report

    Report Number
    0001526350-2019-00825
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K991038
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET. D4 - UDI# - (B)(4). REPORTED ISSUE: ON (B)(6) 2019, IT WAS REPORTED THAT THE DEVICE WAS SHOWING POWER CORD WIRES. DHR REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR THE VP500 VASOPRESS PUMP WITH SERIAL NUMBER (B)(6) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE VP500 VASOPRESS PUMP FOR SERIAL NUMBER (B)(6), THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED BY ZIMMER BIOMET SURGICAL /COMPRESSION THERAPY CONCEPTS (C.T.C.). DEVICE EVALUATIONS RESULTS/INVESTIGATION FINDINGS: PRODUCT REVIEW OF THE VP500 VASOPRESS PUMP PERFORMED BY ZIMMER BIOMET SURGICAL ON JUNE 28, 2019 REVEALED THAT THE POWER CORD HAD BARE WIRES. REPAIR OF THE VP500 VASOPRESS PUMP WAS NOT PERFORMED BY ZIMMER BIOMET SURGICAL DUE TO THE DEVICE BEING SCRAPPED AFTER PRODUCT EVALUATION. PROBABLE CAUSE/ROOT CAUSE: THE REPORTED EVENT " THE DEVICE WAS SHOWING POWER CORD WIRES " WAS CONFIRMED SINCE DURING PRODUCT REVIEW THE POWER CORD HAD BARE WIRES. A DEFINITIVE ROOT CAUSE OF THE POWER CORD DAMAGE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE IT IS UNKNOWN WHAT CAUSED THE DAMAGE TO THE POWER CORD. THE DEVICE WAS SCRAPPED AFTER EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME. THERE WAS 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 · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). PROCODE: JOW. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD SHOWING POWER CORD WIRES. THERE WAS NO PATIENT IMPACT AND NOT AN OUT OF BOX FAILURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926142 VASOPRESS PUMP VASCULAR THERAPY JOW ZIMMER SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1