BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10023# AVALON ELITE 23F, 31CM

    MDR report key: 4990419 · Received August 7, 2015

    Report

    Report Number
    8010762-2015-00878
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS REQUESTED FOR INVESTIGATION BUT NOT PROVIDED BY THE CLAIMING CUSTOMER. ACCORDING TO THE "INSTRUCTION FOR USE I 1.1 I G-158" PAGE 7," A SUTURE TIED DIRECTLY AROUND THE WIRE-REINFORCED SECTION CAN CUT, KINK OR DAMAGE THE CATHETER. ACCORDING TO THE COMPLAINT REPORT A CLAMP WAS APPLIED TO THE WIRE REINFORCED SECTION OF THE EXPOSED PORTION OF THE CANNULA CAUSING SIGNIFICANT ALTERATION AND DAMAGE TO THE INTEGRITY OF THE WIRE. THE CLAIMED FAILURE OCCURRED DUE TO NOT FOLLOWING THE INSTRUCTION FOR USE AND THEREFORE A MALFUNCTION OF THE DEVICE IN QUESTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG REQUESTED THE DEVICE IN QUESTION FOR EVALUATION BUT HAS IT NOT RECEIVED YET. A SUPPLEMENT MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT AT SOME STAGE A CLAMP HAS BEEN APPLIED TO THE WIRE REINFORCED SECTION OF THE EXPOSED PORTION OF THE CANNULA CAUSING SIGNIFICANT ALTERATION AND DAMAGE TO THE INTEGRITY OF THE WIRE. THE THERAPY WAS RECOMMENCED BUT DUE TO LOW FLOW THE CANNULA WAS REPOSITIONED AND DURING THIS PROCESS THE CANNULA HAS TORN AT THE JUNCTION OF WHERE THE WIRE HAD BEEN PREVIOUSLY CLAMPED AND THE UNDERLYING PLASTIC. THEN AIR ENTERED THE ECMO CIRCUIT AND THE FLOW WAS STOPPED AND THE PATIENT WAS WEANED OFF THE SUPPORT WITH POOR SATURATIONS FOR 15 TO 17 MINUTES. DURING THIS TIME THE PATIENT WAS RECANNULATED FEMORALLY AND PLACED BACK INTO SUPPORT. NO FURTHER CONSEQUENCES TO THE TREATED PATIENT WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521146 10023# AVALON ELITE 23F, 31CM DWF MAQUET CARDIOPULMONARY AG 10023#AVALON ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention