BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 3071497 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10023
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12K05052 AND H13A11109 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). THE PATIENT EXPERIENCED PERITONITIS, AND THEY WERE ADMITTED INTO THE HOSPITAL ON THE SAME DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT DURING HOSPITALIZATION INCLUDED VANCOMYCIN IV(DOSE UNKNOWN) AND CEFTAZIDIME- IV(DOSE UNKNOWN). THE PATIENT WAS PRESCRIBED CEFAZOLIN IP (DOSE AND FREQUENCY WAS UNKNOWN) AND VANCOMYCIN IP X1 (DOSE UNKNOWN) FOR TREATMENT AT HOME. THE PATIENT WAS RECOVERING FOR THIS EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172695 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R LOW CALCIUM YELLOW 1.5% SINGLEBAG