BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON ELITE

    MDR report key: 5538405 · Received March 31, 2016

    Report

    Report Number
    8010762-2016-00225
    Event Type
    Death
    Date Received
    March 31, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 23, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2016 01:37 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). MAQUET (B)(4) HAS REQUESTED ADDITIONAL INFORMATION ABOUT THE INCIDENT AND THE ARTICLE AS WELL AS THE LOT NUMBER OF THE CATHETER. THE DEVICE WAS REQUESTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(6) 2016 01:25 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): IT WAS REPORTED THAT DURING PATIENT TREATMENT AIR WAS NOTICED IN THE CIRCUIT AND THE SUPPORT WAS DISCONTINUED. THERE IS NO SPECIFIC PRODUCT PROBLEM CLAIMED BUT IT IS REQUESTED TO INVESTIGATE THE MAQUET PRODUCTS INVOVLED, THE HLS SET 7.0 ((B)(4)) AND THE AVALON CATHETER INVOLVED. ACCORDING TO INFORMATION PERTAINING TO THE AUTOPSY, THE PATIENT EXPIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192909 AVALON ELITE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG AVALON ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death