BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2872947 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07294
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS EVENT INVOLVED A USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A 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. THIS REPORT OF USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED, BECAUSE IT WAS REPORTED BY THE NURSE THAT PATIENT HAD A TOUCH CONTAMINATION. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR 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. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN THE USA OF PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN PD. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. CAUSE OF THE PERITONITIS AND TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER PERITONEAL EFFLUENT CULTURE WAS PERFORMED OR NOT. OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS PROVIDED BY THE NURSE ((B)(4) 2012). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 AND TREATED WITH VANCOMYCIN 500MG IP EVERY 48 HOURS FOR 7 DAYS. THE CAUSE OF THE PERITONITIS WAS "TOUCH CONTAMINATION." THE PATIENT WAS RETRAINED. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THIS EVENT WAS NOT RELATED TO A BAXTER MACHINE OR DISPOSABLE PARTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 59 YR Hospitalization| R DIANEAL PD4