BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123697 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33539
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIRTY FIVE DAYS AFTER EVENT ONSET, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR RECURRENT PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT OF THE EVENT WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT DISCONTINUED PERITONEAL DIALYSIS THERAPY AND WAS STARTED ON HEMODIALYSIS. THE OUTCOME OF THE EVENT WAS NOT REPORTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(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 SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (ORAL, ONE DAY, DOSE NOT REPORTED) AND THEN WAS SWITCHED TO VANCOMYCIN (INTRAVENOUS, DOSE UNKNOWN, DURATION AND FREQUENCY NOT REPORTED) AND ¿AN ANTIBIOTIC THAT STARTED WITH A C¿ (INTRAVENOUS, DOSE UNKNOWN, DURATION AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THREE DAYS. THE CAUSE OF THE EVENT WAS UNKNOWN. AT THE TIME OF THIS REPORT, TREATMENT WITH VANCOMYCIN (2GM, INTRAPERITONEALLY, FREQUENCY NOT REPORTED) AND ¿AN ANTIBIOTIC THAT STARTED WITH A C¿ (INTRAPERITONEALLY, DOSE UNKNOWN, FREQUENCY NOT REPORTED) WAS ONGOING. THE PATIENT WAS RECOVERING FROM THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602867 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R DIANEAL 2.5% ULTRABAG AND SINGLEBAG| HOMECHOICE, TRANSFER SET, MINICAP.