BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3223278 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18166
    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
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT FOR AN ADVERSE EVENT, AS THERE WAS NO REPORTED PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13B20074, H13C18118, AND H13D02078 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).

    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 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323300 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXTENSION SET, HOMECHOICE| DIANEAL PD4 AMBUFLEX| MINICAP TRANSFER SET, MINICAP