BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERSONAL CYCLER MACHINE 100 VOLTS

    MDR report key: 1801815 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02540
    Event Type
    Death
    Date Received
    August 16, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS NOT BE RETURNED TO BAXTER AT TIME THIS MDR WAS CREATED. FOLLOW UP INFORMATION WILL BE SENT IF IT BECOMES AVAILABLE.A 510K NUMBER WILL NOT BE INCLUDED IN THIS MDR. A 510K HAS NOT BEEN ISSUED FOR THIS PRODUCT AS IT IS ONLY DISTRIBUTED OUT SIDE THE UNITED STATES.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF DEATH IN A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD-2 2.5% AND EXTRANEAL THERAPIES. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-2 2.5% AND EXTRANEAL THERAPIES. ON (B)(6)2010, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT HAD DIED ON THAT DAY. CAUSE OF DEATH AND CAUSALITY WERE NOT PROVIDED. FOLLOW-UP INFORMATION WAS OBTAINED BY THE PHYSICIAN. ON AN UNKNOWN DATE IN (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS. ON (B)(6)2010, SHE DIED OF CARDIAC FAILURE. AT THE TIME OF HER DEATH, THE PERITONITIS WAS RESOLVING. PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING UNTIL HER DEATH. THE PHYSICIAN COULD NOT DENY THE POSSIBILITY THAT PERITONITIS, HAD NOT WORSENED THE CARDIAC FAILURE OR HAD HASTENED THE PATIENT?S DEATH. THE PHYSICIAN CONSIDERED PERITONITIS AS NON-SERIOUS. FOLLOW-UP INFORMATION WAS RECEIVED AND THE CAUSE OF DEATH WAS AMENDED FROM CARDIAC FAILURE TO PERITONITIS BACTERIAL. THE PATIENT HAD BEEN HOSPITALIZED FOR AN UNKNOWN REASON. ON (B)(6)2010, SHE DEVELOPED PERITONITIS BACTERIAL. UNSPECIFIED ANTIBIOTIC WERE ADMINISTERED FOR THE EVENT. ON AN UNKNOWN DATE, THE EVENT WAS RESOLVED. ON (B)(6)2010, SHE DEVELOPED PERITONITIS BACTERIAL. AN UNSPECIFIED ANTIBIOTIC WAS ADMINISTERED FOR THE EVENT. ON (B)(6)2010, SHE DIED OF THE EVENT. PD THERAPY WAS ONGOING UNTIL HER DEATH. THE PHYSICIAN BELIEVED THAT THE EVENT WAS POSSIBLY RELATED TO PD THERAPY. AS THE PERITONITIS WAS BACTERIAL, THE PHYSICIAN CONSIDERED THE EVENT WAS NOT RELATED TO PD SOLUTION DIRECTLY. BUT, THE PHYSICIAN COULD NOT DENY THE POSSIBILITY OF CONTAMINATION WHEN PD SOLUTION WAS ADMINISTERED. THIS MDR IS FOR THE PATIENT'S DEATH AN ADDITIONAL MDR WILL BE SENT TO REPORT THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERSONAL CYCLER MACHINE 100 VOLTS SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death