BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920959 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06818
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 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
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THIS REPORT OF PERITONITIS WAS DETERMINED TO BE USE ERROR. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY RELATED LOT NUMBERS (H10G11059, H10H28010, H10H19027), WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. 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 2 INVOLVED IN THIS PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE THE PATIENT DEVELOPED INCONTINENCE. ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE / TOUCH CONTAMINATION. THE NURSE REPORTED THAT "OVER TIME PATIENT IS FAILING, HE TOUCHES HIS TUBING". ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED THAT SAME DAY. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE EVENTS OF INCONTINENCE AND THE PATIENT MADE MISTAKE / TOUCH CONTAMINATION RESOLVED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENTS OF INCONTINENCE AND PATIENT MADE MISTAKE / TOUCH CONTAMINATION.

    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 67 YR Hospitalization DIANEAL PD4 AMBUFLEX