BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1921273 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06828
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER REQUESTED AND RECEIVED THE DEVICE FOR EVALUATION BY THE PRODUCT ANALYSIS LAB (PAL). UPON COMPLETION OF THE EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HP'S STROKE OR THE HP PASSING AWAY ON (B)(6) 2010 . THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. PER THE INITIAL REPORT, THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) PASSED AWAY OVER THREE WEEKS AGO AND SHE NEEDED TO HAVE THE HOMECHOICE (HC) PICKED UP. ON 08NOV2010, BAXTER RECEIVED FOLLOW-UP INFORMATION FROM BAXTER'S GLOBAL PHARMACOVIGILANCE. THIS IS A REPORT FROM A NURSE OF FATAL STROKE IN MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNKNOWN DATE THE PATIENT EXPERIENCED A STROKE. ON (B)(6) 2010, THE PATIENT DIED AS A RESULT OF THE STROKE. TREATMENT INFORMATION WAS NOT PROVIDED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. PERITONEAL DIALYSIS (PD)L THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE PATIENT PREVIOUSLY EXPERIENCED HIGH BLOOD SUGARS ON (B)(6) 2009; VALUES NOT REPORTED TO BAXTER. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF FATAL STROKE WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%.