BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 6997581 · Received November 2, 2017

    Report

    Report Number
    0001954182-2017-00034
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 22, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PK162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) REVIEW FOR INTELLICART FLUID SYSTEM SERIAL NUMBER (B)(4), 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. USING CRM TO QUERY FOR SERIAL NUMBER (B)(4), THE DEVICE WAS NOTED TO HAVE NOT BEEN PREVIOUSLY REPAIRED BY ZIMMER BIOMET SURGICAL. USING VIEW 09-23 FROM THE ETQ RELIANCE SYSTEM, THERE WAS 01 COMPLAINT THAT CONTAINED PART NUMBER: 00514010200, LOT# 0023953 AND COMPLAINT DESCRIPTION WITH ¿LEAKING¿. THE KEYWORD OF ¿LEAKING¿ WAS CHOSEN AS A FILTER BASED UPON THE REPORTED FAILURE OF ¿THE UNIT WAS LEAKING FLUID FROM THE BOTTOM OF THE CART.¿ USING VIEW 09-23 FROM THE ETQ RELIANCE SYSTEM, THERE WAS 24 COMPLAINTS THAT CONTAINED PART NUMBER: 00514010200, COMPLAINT DESCRIPTION WITH THE KEYWORD: ¿LEAKING¿ THE KEYWORD OF ¿LEAKING¿ WAS CHOSEN AS A FILTER BASED UPON THE REPORTED FAILURE OF ¿THE UNIT WAS LEAKING FLUID FROM THE BOTTOM OF THE CART.¿ ON (B)(6) 2017, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT THE UNIT WAS LEAKING FROM THE BOTTOM OF THE CART. THE SERVICE COMPANY WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON (B)(6) 2017, THE TECHNICIAN FOUND THAT THE BOTTOM PLATE OF THE UNIT WAS CRACKED. SO THE EXCHANGE WAS INITIATED. AN EXCHANGE FOR THE NEW CART WAS SCHEDULED. A NEW CART (SN#(B)(4)) WAS SHIPPED FROM (B)(6) TO THE FACILITY (SHIPPING#(B)(4)). ON 26 OCT 2017, THE NEW CART WAS CONFIRMED TO HAVE BEEN DELIVERED TO THE FACILITY AND SERVICE COMPANY WAS DISPATCHED A SERVICE TECHNICIAN TO THE SITE TO PERFORM EXCHANGE. ON 28 NOV 2017, THE TECHNICIAN ARRIVED AT THE SITE AND INSTALLED THE NEW CART. HE THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED AND PLACED THE CART INTO SERVICE WITHOUT FURTHER INCIDENT. THE TECHNICIAN THEN REPACKAGED THE OLD CART SO THAT IT RETURNED TO SERVICE CENTER. THE EXCHANGED CART WAS PICKED UP FROM THE FACILITY. THE EXCHANGE CART WAS CONFIRMED TO HAVE BEEN RETURNED ON 13 DEC 2017. UPON FOLLOW FROM THE RIVERSIDE, IT WAS CONFIRMED THAT UNIT WILL BE REFURBISHED SERVICE WORK ORDER (B)(4) ON 23 NOV 2017. THE ROOT CAUSE OF THE FLUID LEAK FROM THE BOTTOM OF THE CART WAS DUE TO A CRACK ON THE BOTTOM PLATE. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND IT WAS RESOLVED BY EXCHANGING THE CART. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE 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 WAS LEAKING FLUID FROM THE BOTTOM OF THE CART. THE EVENT TIMING WAS UNKNOWN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777022 DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE JCX DORNOCH N/A 0026114

    Patients

    Seq Age Sex Outcome Treatment
    1