BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2201442 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01119
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL WOULD NOT LOAD PROPERLY; IT REMAINED INSIDE THE LOADER. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 4.3MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25032976

    Patients

    Seq Age Sex Outcome Treatment
    1 NA