BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON 13 FRENCH CANNULA

    MDR report key: 7973984 · Received October 17, 2018

    Report

    Report Number
    8010762-2018-00281
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 24, 2018
    Report Date
    January 17, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(6). THE DEFECTIVE PART HAS ARRIVED FOR INVESTIGATION: AN AVALON ELITE 13 FR HAS BEEN RETURNED. THE SAMPLE WAS CONTAMINATED. SAMPLE WAS CLEANED WITH SODIUM HYPOCHLORITE. VISUAL INSPECTION PERFORMED. NO ABNORMALITIES COULD BE DETECTED. THE INTRODUCER COULD BE PULLED OUT OF THE CATHETER NORMALLY AND PUSHED BACK IN AGAIN. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: IT WAS REPORTED THAT AFTER INSERTION OF THE 13 FRENCH AVALON CANNULA INTO THE RIGHT IJ THE OBTERATOR COULD NOT BE REMOVED. THE CANNULA WAS THEN REMOVED AND ECLS SUPPORT WAS INITIATED THROUGH CENTRAL CANNULATION. ADDITIONAL INFORMATION: THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT REPORTED. (B)(4).

    Description of Event or Problem · 0

    REF.: (B)(4). CUSTOMER REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817020 AVALON 13 FRENCH CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention