BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970755 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01036
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH IMIPENEM (500MG, BID, IP), AMIKACIN (250MG, LOADING DOSE, IP) AND AMIKACIN (150MG, DAILY, IP) CONTINUING. DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED; THEREFORE THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVING. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE. A CAUSALITY STATEMENT WAS NOT REPORTED 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 46 YR Hospitalization| R DIANEAL PD2 ULTRABAG