BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1903729 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06033
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOTS, H10G11042, H10F21084, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF THREE COMPLAINTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED BY A USA NURSE OF PERITONITIS AND VENTRICULAR TACHYCARDIA IN AN APPROXIMATELY (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. ON (B)(6) 2010, THE PATIENT EXPIRED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF DEATH. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE INDICATED, ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA. ON (B)(6) 2010, THE PATIENT DIED AS A RESULT OF THE VENTRICULAR TACHYCARDIA. TREATMENT INFORMATION WAS NOT PROVIDED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). PER THE NURSE, THE EVENT OF DEATH WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R DIANEAL PD4 AMBUFLEX