BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2895331 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00177
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE IN RELATION TO THE PREVENTION OF THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION WHICH CAUSED PERITONITIS ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. ON (B)(6) 2012, FURTHER INFORMATION WAS RECEIVED FROM THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PDRN STATED THAT THE PERITONITIS ONSET AND HOSPITALIZATION DATES ARE CORRECT. THE PERITONITIS WAS DIAGNOSED ON (B)(6) 2012. THE PATIENT DID NOT FULLY RECOVER FROM THE EVENT AND EXPERIENCED A RECURRENCE OF THE PERITONITIS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 FOR THE RECURRING PERITONITIS EVENT. NO ADDITIONAL INFORMATION WAS RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3770 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization DIANEAL PD4 ULTRABAG