BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4092344 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31453
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ONE DAY AFTER THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON THE SAME DAY AS THE HOSPITALIZATION, THE PATIENT WAS TREATED WITH VANCOMYCIN (1 GRAM, DAILY, INTRAPERITONEALLY [IP]) FOR THE PERITONITIS. THE TREATMENT WITH VANCOMYCIN WAS STOPPED AFTER NINE DAYS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573131 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R DIANEAL 2.5% PD4 ULTRABAG, HOMECHOICE| DIANEAL 2.5% PD4 AMBUFLEX, MINICAP| TITANIUM ADAPTER, MINICAP TRANSFER SET.