BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2190592 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10249
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY CONSUMER FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, FURTHER DESCRIBED AS PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2011 THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (2 GM, IP, LOADING DOSE), AMIKACIN (125 MG, IP, ONCE DAILY) AND CEFEPIME (1000 MG, IP, ONCE DAILY). REMEDIAL THERAPY WITH AMIKACIN AND CEFEPIME WAS ONGOING. THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE AN OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS CAUSED BY A BREAK IN ASEPTIC TECHNIQUE, AND UNRELATED TO DIANEAL THERAPY. THE REPORTER DID NOT COMMENT ON WHETHER THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS RELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention DIANEAL PD2 ULTRABAG