BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2874024 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07363
    Event Type
    Injury
    Date Received
    December 14, 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
    IN, 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 THERE WAS A BREACH IN ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE WAS UNDETERMINED. 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.

    Description of Event or Problem · 1

    DURING AN UNRELATED CALL, THE NURSE REPORTED THE PATIENT HAD HAD PERITONITIS. GLOBAL PHARMACOVIGILAN PROVIDED THE FOLLOWING INFORMATION, WHICH WAS OBTAINED FROM THE NURSE ((B)(6) 2012). ON AN UNKNOWN DATE IN 2012, THE PATIENT EXPERIENCED THE ONSET OF PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON AN UNKNOWN DATE IN 2012, THE PATIENT WAS HOSPITALIZED (ADMITTING DIAGNOSIS NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE. IN (B)(6) 2012, THE PATIENT WAS RETRAINED ON THE TECHNIQUE. REPORTEDLY THE PERITONITIS WAS NOT RELATED TO ANY BAXTER DEVICE OR DISPOSABLE PART. OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. THE NURSE REFUSED TO GIVE ANY ADDITIONAL INFORMATION.

    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 17 YR Hospitalization DIANEAL PD2