BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3800067 · Received May 8, 2014

    Report

    Report Number
    1416980-2014-14821
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A11033 AND H14A27120 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED TWO DAYS PRIOR TO THE EVENT FOR PD CATHETER REPOSITIONING ISSUES. WHILE HOSPITALIZED, THE PATIENT ACQUIRED PERITONITIS MANIFESTED AS CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE SAME DAY AS DIAGNOSIS, THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) FOR FIVE DAYS (DOSE AND FREQUENCY NOT REPORTED) AND CEFTAZIDIME IP DAILY FOR FOURTEEN DAYS (DOSE NOT REPORTED). THE PATIENT WAS DISCHARGED SEVEN DAYS AFTER ADMISSION AND REPORTED TO BE RECOVERING FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279489 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R DIANEAL PD4 1.5% AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, MINICAP TRANSFER SET