BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1891259 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05259
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 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 PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER-EMPLOYED (B)(6) FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE IN 2010, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH IMIPENEM 125 MG INTRAPERITONEALLY, ONCE DAILY. THIS ANTIBIOTIC THERAPY, AS WELL AS THE DIANEAL PD2 ULTRABAG THERAPY WERE ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. THE REPORTER BELIEVED THE PERITONITIS WAS CAUSED BY THE BREAK IN ASEPTIC TECHNIQUE AND NOT RELATED TO THE DIANEAL THERAPY. THE REPORTER DID NOT PROVIDE A CAUSALITY STATEMENT 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 64 YR Required Intervention DIANEAL PD2 ULTRABAG