BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1994075 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02063
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 26, 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 REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS (H10H15017, H10I19025) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ASSIGNABLE CAUSE WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 3 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL FOR AN UNRELATED ALARM, THE REGISTERED NURSE STATED THE PATIENT HAD PERITONITIS AND HAS RECOVERED. SHE REPORTED THAT THE PATIENT WAS CONTINUING THEIR PERITONEAL DIALYSIS (PD) THERAPY SUCCESSFULLY. BAXTER CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ON (B)(6) 2011 REGARDING THIS INCIDENT OF PERITONITIS AND SHE STATED THAT SHE WAS UNABLE TO GIVE OUT ANY INFORMATION REGARDING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL LOW CAL (B)(4)| HOME CHOICE CYCLER