BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2944450 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02990
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS IS CONFIRMED BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, DESCRIBED BY THE NURSE AS THE PATIENT VOMITING ON HIS TRANSFER SET AND THEN USING IT, WHICH CAUSED PERITONITIS; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED SINCE IT IS UNCERTAIN WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT FROM A REGISTERED NURSE (RN) IN THE USA OF A BREAK IN ASPETIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY. DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASPETIC TECHNIQUE, DESCRIBED BY THE NURSE AS THE PATIENT VOMITING ON HIS TRANSFER SET AND THEN USING IT AND CAUSING CONTAMINATION. THE RN STATED THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED THE START OF PERITONITIS AND WAS ADMITTED INTO THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASPETIC TECHNIQUE AND CONTAMINATION. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSAGE AND ROUTE NOT REPORTED). ON (B)(6) 2013, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL BUT THE RN DECLINED TO PROVIDE INFORMATION ON THIS HOSPITALIZATION BECAUSE SHE STATED "IT WAS NOT RELATED TO DIALYSIS". THE PATIENT WAS RETRAINED ON PROPER ASEPTIC PROCEDURES AND WAS REPORTED TO BE RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48656 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R DIANEAL 2.5% ULTRABAG