BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3

    MDR report key: 3770363 · Received January 21, 2014

    Report

    Report Number
    2242352-2014-00010
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 30, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE. THERE WAS BLOOD INSIDE THE DELIVERY TUBE AND ON THE SEAL. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY, ANCHOR TUB AND SEAL WERE OUTSIDE OF THE DELIVERY TUBE. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. ADDITIONAL EVALUATION IS REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HS III PROXIMAL SEAL WOULD NOT LOAD PROPERLY INTO THE DELIVERY TUBE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51047 HS III PROXIMAL SEAL SYSTEM 4.3 CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25081728

    Patients

    Seq Age Sex Outcome Treatment
    1 NI