BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3223300 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18170
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13B23052, H13C06048, AND H13D11046 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT STARTED TAKING PROTEIN BAGS ALSO (REPORTED AS NUTRITIONAL SOLUTION, NON-BAXTER PRODUCT) FOR AN UNREPORTED INDICATION. ON AN UNREPORTED DATE IN THE SAME MONTH AS THIS REPORT, THE PATIENT EXPERIENCED DIARRHEA. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED AS PAINS IN THE STOMACH. ON THE SAME DATE, THE PATIENT WAS TREATED WITH CIPROFLOXACIN (ORALLY, ONCE A DAY, DOSE NOT REPORTED) FOR THE PERITONITIS. TWO DAYS LATER, CIPROFLOXACIN WAS STOPPED. ON AN UNREPORTED DATE IN THE SAME MONTH AS THIS REPORT, THE PATIENT STARTED WITH TAZICEF (DOSE AND FREQUENCY NOT REPORTED) IP, TO TREAT THE PERITONITIS. THE NURSE BELIEVED THAT THE CAUSE OF PERITONITIS WAS THE DIARRHEA. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING FROM THE EVENT AND DIANEAL THERAPY WAS ONGOING. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323497 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4 AMBUFLEX, HOMECHOICE| MINICAP, MINICAP TRANSFER SET