BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART - REFURBISHED

    MDR report key: 10033196 · Received May 7, 2020

    Report

    Report Number
    0001954182-2020-00020
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    January 22, 2020
    Report Date
    May 7, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT REVIEW OF THE INTELLICART (B)(4) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON 23 JANUARY 2020 REVEALED THAT THE POWER IV POLE WAS SPINNING AND FORCEFULLY PULLED THE MAX LIMIT CABLE FROM THE CONTROL BOARD. THE FILTER ALSO SHOWED SIGNS OF SMOKE AND A FOREIGN OBJECT WAS FOUND IN CYLINDER 1. REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON 23 JANUARY 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: POWER IV POLE CLAMP (PN70195, LN41640), BOARD (PN70064, LN42250), PM KIT (PN70068, LN N/A) THE DEVICE, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM/PART FAMILY AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. 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 AFTER SURGERY THAT THE UNIT'S IV POLE WAS STUCK. DURING EVALUATION OF THE DEVICE, THE TECHNICIAN NOTED THAT THE FILTER SHOWED SIGNS OF SMOKE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499384 DUO FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1