BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 1877351 · Received October 20, 2010

    Report

    Report Number
    2015691-2010-14227
    Event Type
    Death
    Date Received
    October 20, 2010
    Date of Event
    March 31, 2010
    Report Date
    September 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 09/21/2010 AND 09/28/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    A CALL WAS MADE TO THE SURGEON'S OFFICE ON (B)(6) 2010, AND IT WAS LEARNED THAT THE PATIENT EXPIRED DURING SURGERY. IMPLANT DURATION WAS ZERO DAYS. NO FURTHER DETAILS WERE PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN. A COPY OF THE DISCHARGE SUMMARY WAS REQUESTED, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. NO FURTHER DETAILS WERE PROVIDED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW LIPASE (LIP) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED USING DIFFERENT LIP REAGENT LOT AND HIGH RESULTS WERE OBTAINED AND CORRECTED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-09J2232

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death