BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 10119025 · Received June 4, 2020

    Report

    Report Number
    0001954182-2020-00022
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 4, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI #: (B)(4). PRODUCT REVIEW OF THE DUO FLUID CART SERIAL NUMBER (B)(4) BY ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON MAY 05, 2020 REVEALED THAT THE UNIT HAD VACUUM ISSUE, VACUUM SENSOR 2 ERRORS. ONE OF THE VACUUM PUMP FUSES WAS BAD. THE FUSE WAS REPLACED BUT THE VACUUM PUMP STILL WOULD NOT RUN. WHILE REMOVING THE CAPACITOR FOR REPLACEMENT, THE VACUUM PUMP WIRES WERE DAMAGED. REPAIR OF THE DEVICE WAS PERFORMED BY ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON MAY 05, 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: ITEM# 70098, LOT# 0042839, INTELLICART VACUUM PUMP KIT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM(S)/PART FAMILY AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION(S). COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT IS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE SURGERY THAT THE UNIT HAD VACUUM ISSUES, VACUUM SENSOR 2 ERRORS. DURING AN INVESTIGATION OF THE DEVICE, FRAYED/BARED WIRES WERE DISCOVERED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583841 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0040347

    Patients

    Seq Age Sex Outcome Treatment
    1