BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1840529 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03607
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF TRANSFER SET GOT LOOSE AND THE T SET HAD NOT BEEN CHANGED FOR 3 MONTHS (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE TRANSFER SET GOT LOOSE AND THE T SET HAD NOT BEEN CHANGED FOR 3 MONTHS. ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS (MANIFESTATIONS NOT REPORTED). THE REPORTER BELIEVED THE CAUSE OF THE PERITONITIS WAS THAT THE TRANSFER SET GOT LOOSE AND THE T SET HAD NOT BEEN CHANGED FOR 3 MONTHS. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE IN (B)(6)2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH UNIZOX (1 GM, DAILY, INTRAVENOUS) AND TAZIN (4.5 GM, TWICE A DAY, INTRAVENOUS). ON (B)(6)2010, THE PATIENT RECEIVED A LOADING DOSE OF VANCOMYCIN (1 GM, INTRAPERITONEAL (IP)). THE OUTCOMES OF THE TRANSFER SET GOT LOOSE AND THE T SET HAD NOT BEEN CHANGED FOR 3 MONTHS AND PERITONITIS WERE NOT REPORTED. THE PATIENT REMAINED HOSPITALIZED. PD THERAPY WAS ONGOING. THIS MEDICAL DEVICE REPORT (MDR) ADDRESSES THE TRANSFER SET AND A SEPARATE MDR WILL BE SUBMITTED ADDRESSING THE T SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIANEAL PD2 ULTRABAG