BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3011901 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06649
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 7, 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). ON (B)(4) 2013, FOLLOW UP INFORMATION WAS RECEIVED RELATED TO THE EVENT. THE PATIENT WAS TREATED WITH CEFA AND FORTUM FOR THE PERITONITIS. THE PATIENT RECOVERED FROM THE PERITONITIS BUT REMAINED HOSPITALIZED FOR PNEUMONIA. ON A LATER DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE PNEUMONIA. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DETERMINED, 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.

    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 AND ABDOMINAL PAIN, DUE TO THE PERITONITIS. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND 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. THE PATIENT WAS BORN IN 1957.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113686 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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