BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073490 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05255
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 FOR THIS INCIDENCE OF PERITONITIS. AS THE PATIENT DISCARDS SUPPLIES AFTER EACH USE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10K22067, H11B11042) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER CONTACTED BAXTER AND VERBALIZED HE HAD JUST BEEN RELEASED FROM THE HOSPITAL. ON (B)(6) 2011 BAXTER'S (B)(4) CONTACTED THE PATIENTS PERITONEAL DIALYSIS RN THAT ON AN UNKNOWN DATE THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON UNKNOWN DATE PD EFFLUENT CULTURES WERE TAKEN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. SHE STATED THAT THE CAUSE OF THE PERITONITIS WAS MOST LIKELY FROM TOUCH CONTAMINATION. THE TREATMENT FOR THE PERITONITIS IS UNKNOWN. THE PATIENT WAS RECOVERING WHILE CONTINUING PD THERAPY WITHOUT ANY PROBLEMS. THERE WAS NO ALLEGATION AGAINST ANY BAXTER SOLUTION OR DEVICE. NO FURTHER INFORMATION 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 60 YR Hospitalization| R HOME CHOICE CYCLER| DIANEAL LOW CAL (PD4) AMBUFLEX