BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 1475539 · Received September 17, 2009

    Report

    Report Number
    2015691-2009-11601
    Event Type
    Injury
    Date Received
    September 17, 2009
    Date of Event
    August 3, 2009
    Report Date
    August 26, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DISPLAY. THIS EVENT OCCURRED DURING USE. THE PATIENT WAS NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE CARE GIVER (CG) CONFIRMED THERE WERE FOUR SUPPLY BAGS CONNECTED. THE TSR HAD THE HOME PATIENT (HP) BEND THE BROKEN FRANGIBLE BACK AND FORTH. THE TSR ALSO HAD THE HP CHECK EACH LINE FOR KINKS AND CLOSED CLAMPS. THE HP RESTARTED PRIMING. THE HC ALARMED WITH RELOAD SET 161. THE TSR EXPLAINED ALARM AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THE CG WILL CALL BACK WITH ANY PROBLEMS. THE HP WILL START OVER WITH NEW SUPPLIES. THE PROBABLE CAUSE WAS A CRACKED CASSETTE. THE CALL WAS COMPLETED AND THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER A IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-09C0616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention