BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1841138 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03616
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 3, 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 DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6)2010, THE PATIENT BEGAN TREATMENT WITH VANCOTECH 2GM INTRAPERITONEAL (IP) ONCE DAILY, GENTAMYCIN 20MG IP ONCE DAILY AND LINID 600MG ORALLY ONCE DAILY. AT THE TIME OF REPORTING, THE EVENT OF PERITONITIS WAS RESOLVING AND THE PATIENT CONTINUED WITH VANCOTECH, GENTAMYCIN AND LINID. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. PD THERAPY CONTINUED.

    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 75 YR Required Intervention DIANEAL PD2 ULTRABAG