BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1952406 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00242
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10I16047, H10H17013), WITH NO DEFECTS NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (DOSE, FREQUENCY) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT'S "DRAIN BAG CAME BACK CLOUDY". ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED THAT SAME DAY. THE CAUSE OF THE PERITONITIS AND CLOUDY DRAIN BAG WERE UNKNOWN. TREATMENT INFORMATION WAS NOT PROVIDED. DIANEAL THERAPY WAS ONGOING. THE NURSE ANTICIPATED THAT THE PATIENT WOULD BE DISCHARGED ON (B)(6) 2010. THE PATIENT WAS RECOVERING. PER THE NURSE, THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD2 AMBUFLEX THERAPY.

    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 16 YR Hospitalization DIANEAL PD2 AMBUFLEX