BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2212079 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10723
    Event Type
    Death
    Date Received
    August 15, 2011
    Date of Event
    November 1, 2010
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PAL PERFORMED AN EXTERNAL/INTERNAL INSPECTION PER FOR THE RITE FAILURE RLS152 (VOLUMETRIC STANDARD RIGHT PRESSURE LEAK). THE DEVICE WAS RECEIVED OPERATIVE AND IN FAIR CONDITION. THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL FAILED AND THE ELECTRICAL SAFETY ANALYZER TEST PASSED. THE RITE ENCOUNTERED ISSUE OF RLS152 WAS CONFIRMED VIA THE DISPLAY ON THE DEVICE. THE INTERNAL EVALUATION OF THE DEVICE REVEALED CUT TRANSDUCER TUBING BETWEEN THE DIGITAL PRINTED CIRCUIT BOARD (PCB) VOLUMETRIC STANDARD RIGHT PRESSURE TRANSDUCER AND THE MANIFOLD. THE ASSIGNABLE CAUSE FOR RLS152 WAS DETERMINED TO BE CUT VOLUMETRIC STANDARD RIGHT (VSR) PRESSURE TRANSDUCER TUBING. THE DEVICE WAS SENT TO SERVICE; ALL TRANSDUCER TUBING WAS IDENTIFIED FOR REMOVAL. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION AND FAILED THE RETURN INSTRUMENT TEST EVALUATION FUNCTIONAL TEST WITH A RELOAD SET 152 ALARM. THE DEVICE WAS RECEIVED OPERATIVE IN FAIR CONDITION. THE ASSIGNABLE CAUSE FOR THE RELOAD SET 152 ALARM WAS DETERMINED TO BE A CUT TRANSDUCER TUBING. THE DEVICE WAS SENT TO SERVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER (B)(4). FURTHER INVESTIGATION REVEALED THE HOME PATIENT EXPIRED. ON (B)(6) 2011, BAXTER SPOKE WITH THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT THE HP HAD EXPIRED A FEW MONTHS BACK AND DECLINED TO DISCLOSE FURTHER INFORMATION. ON (B)(6) 2011, BAXTER SPOKE WITH THE SON OF THE HP WHO STATED THAT THE HP WAS HOSPITALIZED AT THE TIME OF DEATH, (B)(6) 2010, WITH ABDOMINAL PAIN AND AN ABDOMINAL INFECTION. PERITONEAL DIALYSIS WAS ONGOING AT THE TIME OF DEATH. THE SON STATED THAT THERE WERE NO KNOWN ISSUES WITH ANY OF THE BAXTER PD PRODUCTS. CULTURE RESULTS AND TREATMENT WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death