BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON ELITE

    MDR report key: 11435321 · Received March 8, 2021

    Report

    Report Number
    8010762-2021-00151
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 25, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A LEAK OF AN AVALON CANNULA DURING TREATMENT WAS REPORTED. BONE WAX WAS USED TO STOP THE LEAK. THE CANNULA WAS INVESTIGATED IN THE GETINGE LABORATORY ON (B)(6) 2021 WITH FOLLOWING RESULTS: DURING TIGHTNESS TEST A LEAKAGE OF THE CANNULA COULD BE CONFIRMED. UPON VISUAL INSPECTION A CRACK WAS DETERMINED. THE EXACT CAUSE FOR THE NOTED CRACK COULD NOT BE DETERMINED. NEVERTHELESS ACCORDING TO THE RISK MANAGEMENT FILE THE FOLLOWING PROBABLE CAUSES COULD CONTRIBUTE TO THE REPORTED MALFUNCTION: MANUFACTURING ISSUE; ROUGH HANDLING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON 2021-03-04 FOR LOT#240442 BY THE SUPPLIER (B)(4). NO ANOMALIES WERE FOUND FOR ANY SUB-ASSEMBLY OR FINAL ASSEMBLY DHR. BASED ON THIS PRODUCTION RELATED INFLUENCES COULD BE EXCLUDED. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "LEAKAGE" COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED TO BE RETURNED AFTER TREATMENT. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A 31 FR. AVALON CANNULA HAD A LEAK. BONE WAX WAS PUT ON THE LEAK TO CONTINUE THE TREATMENT. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334895 AVALON ELITE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH 10031#AVALON ELITE 31F, 31CM 230442

    Patients

    Seq Age Sex Outcome Treatment
    1