BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2942338 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02858
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 15, 2013
    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). A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. THIS REPORT WAS CONFIRMED, AS IT WAS REPORTED THAT THERE WAS A BREAK IN ASEPTIC TECHNIQUE (DESCRIBED AS A TOUCH CONTAMINATION). THEREFORE THE ASSIGNABLE CAUSE WAS DETERMINED TO BE USER ERROR. 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 SPONTANEOUS REPORT FROM A CONSUMER, WITH SUPPLEMENTAL INFORMATION FROM A NURSE, OF TOUCH CONTAMINATION AND PERITONITIS (CULTURE POSITIVE (B)(6)) COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2012, THE PATIENT BEGAN CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CUSTOMER CONTACTED BAXTER CUSTOMER SERVICES AND REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS TOUCH CONTAMINATION. THE TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THE EVENT. PD THERAPY WAS ONGOING. THE NURSE STATED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. ON (B)(6) 2013, PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE REGARDING THE REPORTED EVENT AND THE FOLLOWING INFORMATION WAS OBTAINED. ON AN UNREPORTED DATE, THE PATIENT HAD A HOME VISIT FROM THE NURSE AND THE NURSE RETRAINED THE PATIENT ON PROPER ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46183 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization DIANEAL LOW CALCIUM ULTRABAG.