BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1585147 · Received January 25, 2010

    Report

    Report Number
    2015691-2010-12567
    Event Type
    Death
    Date Received
    January 25, 2010
    Date of Event
    October 15, 2009
    Report Date
    January 6, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. THE CAUSE OF DEATH WAS NOT PROVIDED; HOWEVER, IT WAS LEARNED THAT THE EVENT WAS NOT DEVICE RELATED. THE DEVICE HAS BEEN DISASSOCIATED FROM THE EVENT BY THE HEALTH-CARE PROVIDER. THEREFORE, IT HAS BEEN DETERMINED THAT THIS EVENT IS NO LONGER REPORTABLE TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.5 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 235 MG/DL ON ADVANTAGE SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 83 MG/DL ON ADVANTAGE SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING SUPPRESSED CK RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR TWO PATIENTS. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LAB FOR PATIENT #1. THE CUSTOMER RERAN DILUTED SAMPLES AND GOT HIGHER RESULTS. THE RESULT FOR PATIENT #1 WAS AMENDED AND REPORTED. BY THE TIME THE CORRECTED RESULT WAS AMENDED FOR PATIENT #1, THE PATIENT HAD ALREADY BEEN TRANSFERRED TO A DIFFERENT HOSPITAL. THERE WAS NO AFFECT TO PATIENT #2 SINCE THE ERRONEOUS RESULT FOR THIS PATIENT WAS NOT REPORTED OUTSIDE OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09F1280

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death