BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1813322 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02835
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 5, 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 PATIENTS DISCARD 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 (B)(4) OF BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD)THERAPY. ON AN UNREPORTED DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS "PATIENT MADE MISTAKE". ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED (REPORTED INDICATION WAS PERITONITIS) AND DIAGNOSED WITH PERITONITIS ON (B)(6)2010 (MANIFESTATIONS NOT REPORTED). ON (B)(6)2010, THE PATIENT WAS TREATED WITH A LOADING DOSE OF IP AZTREONAM (250 MG). THE PATIENT WAS ALSO TREATED WITH IP GENTAMYCIN, 40 MG, ONCE DAILY, ((B)(6)2010 TO PRESENT). THE OUTCOME FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WAS UNKNOWN. THE PATIENT REMAINED HOSPITALIZED. PD THERAPY CONTINUED. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE. THE NURSE REPORTED THAT THE ROOT CAUSE OF THE PERITONITIS WAS "PATIENT MADE MISTAKE/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 72 YR Hospitalization| R