BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1813324 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02836
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 6, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, 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 INDIA OF BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. THE OUTCOME OF THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN AND THE PATIENT REMAINED HOSPITALIZED. PD THERAPY AND REMEDIAL THERAPY WITH REFLIN, ORZID, AMIKACIN, AND HEPARIN WERE ONGOING. THE REPORTER BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 57 YR Hospitalization| R