BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1921180 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06823
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10F04031, H10G12115, H10G18013), WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENT. IT WAS NOT REPORTED WHETHER THE EVENT RESOLVED. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI AND DIANEAL PD4 AMBUFLEX THERAPY. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    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 40 YR Other DIANEAL PD4 AMBUFLEX