BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3011909 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06646
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR. THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THE PROBLEM COULD NOT BE CONFIRMED NOR COULD A CAUSE BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS AND REMEDIAL TREATMENT WAS DISCONTINUED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, COINCIDENT WITH THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT EXPERIENCED CLOUDY EFFLUENT, AS A RESULT OF THE PERITONITIS, AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS TREATED WITH CEFA AND FORTUM (IP, DOSES AND FREQUENCIES NOT REPORTED) FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113965 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5%