BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1702587 · Received May 28, 2010

    Report

    Report Number
    2015691-2010-13451
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    March 15, 2010
    Report Date
    April 29, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH A RELATED EVENT OF THIS PATIENT. (B) (4). A DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS APPLY SAMPLE ISSUES. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) AND CKMB RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS. SUBSEQUENT TESTING ON A DIFFERENT INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LEARNED THROUGH THE OPERATIVE REPORT RECEIVED FOR A RELATED EVENT THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1.33 MONTHS, DUE TO ENDOCARDITIS AND AORTIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800TFX R-09D0961

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention