BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1668367 · Received April 28, 2010

    Report

    Report Number
    1423500-2010-00610
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B) (4). CORRESPONDENCE WAS SENT TO THE FACILITY REQUESTING INFORMATION RELATED TO THE PRIMARY AND SECONDARY CAUSES OF DEATH, AND IF AN AUTOPSY WAS PERFORMED. THE FACILITY NURSE COORDINATOR INDICATES, THERE IS NO ADDITIONAL INFORMATION AVAILABLE RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B) (4). THE HOMECHOICE (B) (4) WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) FOR THE REPORTED DIFFICULTY OF HOME PATIENT PASSED AWAY. PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST AND THE HOMECHOICE RITE ELECTRICAL TEST. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    THIS COMPLAINT RELATES TO THE FEMALE PATIENT THAT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS ATTEMPTED BUT NOT USED DUE TO OVERSENSING AND PACING PAUSES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL TECHNICIAN CALL THE BAXTER TECHNICAL SERVICE CENTER STATING, HE HAD TWO HOMECHOICE (HC) DEVICES THAT HAD BEEN USED BY TWO DIFFERENT PATIENTS. BOTH PATIENTS HAD CODED AND ONE PATIENT EXPIRED. THE BIOMEDICAL TECHNICIAN REQUESTED THAT THE DEVICE BE PICKED AND SENT TO BAXTER FOR EVALUATION. THE BIOMEDICAL TECHNICIAN REQUESTED A CUSTOMER LETTER WITH THE EVALUATION RESULTS. THIS COMPLAINT WILL BE FOR PATIENT ONE USING THE HC DEVICE (B) (4). THIS COMPLAINT IS FOR THE PATIENT WHO CODED AND EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R