BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, CANNULA AND TUBING VASCULAR

    MDR report key: 6041655 · Received October 19, 2016

    Report

    Report Number
    8010762-2016-00635
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 29, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISPOSED BY THE HOSPITAL; THEREFORE NO MANUFACTURER LABORATORY INVESTIGATION WAS POSSIBLE. A LOT # OF THE PRODUCT WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE A DHR REVIEW WAS NOT POSSIBLE. BASED ON THIS A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. A (B)(4) TREND SEARCH WAS PERFORMED FOR P/N 70106.3540 RELATED TO GUIDEWIRE WOULD NOT PASS THROUGH AND NO SIMILAR COMPLAINT WAS FOUND AT THIS TIME. DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED. THIS FAILURE WAS DETERMINED TO BE THE FIRST OF ITS KIND AND IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING PROCESS. IF A TREND OCCUR, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION OF APPLICABLE INVESTIGATION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    "THE CUSTOMER STATED THAT DURING INSERTION OF A IJ CANNULA, THE VEIN WAS ACCESSED WITH THE NEEDLE USING THE NEEDLE ASSEMBLY ON THE VAK KIT. AN ATTEMPT TO PASS THE VAK KIT GUIDEWIRE WAS MADE, BUT THE GUIDEWIRE WOULD NOT PASS SMOOTHLY THROUGH THE NEEDLE. THE GUIDEWIRE WAS PULLED BACK SLIGHTLY FOR REPOSITIONING, BUT DURING RETRACTION, THE WIRE SNAGGED ON THE NEEDLE. THIS REQUIRED BOTH THE NEEDLE AND THE GUIDEWIRE TO BE REMOVED FROM THE PATIENT. THE VEIN WAS RE-ACCESSED, AND A DIFFERENT (COMPETITIVE) WIRE WAS USED WITHOUT INCIDENT. NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690483 CATHETER, CANNULA AND TUBING VASCULAR CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG 12210 VAK KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR