BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1598739 · Received February 12, 2010

    Report

    Report Number
    2015691-2010-12681
    Event Type
    Death
    Date Received
    February 12, 2010
    Date of Event
    August 4, 2009
    Report Date
    January 13, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K833763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD 3 OTHER DEVICES IMPLANTED. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), THE OPERATIVE REPORT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A DISCONNECTION THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 1. THE HOME PATIENT (HP) STATED THAT ONE OF HIS SUPPLY BAGS ROLLED OFF THE TABLE AND FELL ON THE FLOOR. THE SUPPLY LINE DISCONNECTED FROM THE BAG AND THE HP PRESSED STOP AND CALLED BAXTER FOR DIRECTION. GTS ASSISTED THE HOME PATIENT (HP) WITH ENDING THERAPY AND RESTART WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.03 MONTHS. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED, HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED. PER THE OPERATIVE REPORT OF (B) (6) 2009, THERE WAS LARGE AMOUNTS OF BLEEDING DURING THE OPERATION. ATTEMPTS WERE MADE TO CONTROL THE BLEEDING. "WE HAD CONTACTED THE FAMILY AND THEY WERE WELL APPRISED OF THE GRAVE SITUATION AS WE WENT TO THE INTENSIVE CARE UNIT WITH THE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATOR. HE LEFT THE OPERATING ROOM IN VERY, VERY CRITICAL AND UNSTABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-09E1131

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death