BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2210359 · Received August 12, 2011

    Report

    Report Number
    1423500-2011-10667
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    November 1, 2010
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (H10H16056, H10G10036 AND H10G31057) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF THREE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER SPOKE WITH THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING A RETURNED HOME CHOICE DEVICE WHO STATED THAT THE HOME PATIENT (HP) HAD EXPIRED A FEW MONTHS BACK. ON (B)(6) 2011, BAXTER SPOKE WITH A 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 (PD) 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. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death| H| R HOMECHOICE| LOCAL (PD4) ULTRABAG| LOCAL (PD4) AMBUFLEX