BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2971650 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04296
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CAN NOT BE CONDUCTED. THIS CONDITION WAS CONFIRMED, AS IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A USE 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

    A PATIENT CALLED TO REPORT THAT THEY WERE HOSPITALIZED DUE TO PERITONITIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND AT THE SAME TIME WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ABOUT A WEEK LATER, AND WAS CONSIDERED TO BE RECOVERED. THE PATIENT HAD STATED THAT WATER HAD GOTTEN INTO THEIR LINES. FOLLOW UP WITH THE NURSE WAS PERFORMED. HOWEVER, THE NURSE DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76851 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization DIANEAL 1.5%, HOMECHOICE