BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 1894515 · Received November 9, 2010

    Report

    Report Number
    2015691-2010-14336
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 12, 2010
    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

    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 10/13/2010 AND 10/20/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE ALARM LOG FOR A RELATED REPORT, THE HOME PATIENT (HP) REPORTED A CHECK PATIENT LINE ALARM. THE HP STATED FLUID STARTED COMING OUT OF THE PATIENT LINE. THE HP CLOSED THE CLAMP ON THE PATIENT LINE DURING PUMPING. THE HP THEN OPENED THE DOOR TO START OVER WITH NEW SUPPLIES. GTS EXPLAINED THE ALARMS AND ASSISTED THE HP WITH GETTING BACK TO SELF TESTING WITH A NEW CASSETTE IN THE MACHINE. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP REGARDING THE REPORTED PROBLEM. THE HP STATED THAT HE WAS NOT USED TO THE MACHINE THE NIGHT OF THIS REPORT. HE DID NOT REMEMBER WHAT HE DID AND COULD NOT RECALL ANY FURTHER DETAILS. THE HP CONFIRMED NOTHING UNUSUAL WAS NOTED WITH THE SUPPLIES. THE HP CONFIRMED HE HAS RESUMED THERAPY WITHOUT COMPLICATIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.

    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-10A0166

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention