BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2983131 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04922
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP INFORMATION ((B)(4) 2013): FOLLOW- WAS RECEIVED FROM THE PHYSICIAN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT RECEIVED TREATMENT FOR FOURTEEN DAYS WITH VANCOMYCIN AND FORTUM (INTRAPERITONEAL; THE DOSES AND FREQUENCIES WERE NOT REPORTED). FOR THE NEXT FOUR DAYS, THE PATIENT RECEIVED CLAMOXYL(AMOXICILLIN) (BY MOUTH; THE DOSE AND FREQUENCY WERE NOT REPORTED). ON THE TWENTY-SECOND DAY OF HOSPITALIZATION, UNTIL AN UNREPORTED DATE, THE PATIENT RECEIVED TREATMENT WITH TIENAM (IMIPENEME, CILASTATINE) AND VANCOMYCIN (IV; THE DOSES AND FREQUENCIES WERE NOT REPORTED). TWENTY-EIGHT DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED, AS THERE WAS NO SAMPLE FOR EVALUATION AND NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED DURING THE REPORT. NO ASSIGNABLE CAUSE COULD 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 THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS TREATED FOR 15 DAYS WITH VANCOMYCIN AND FORTUM (DOSES, ROUTES, AND FREQUENCIES NOT REPORTED). THE OUTCOME OF PERITONITIS WAS NOT RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87559 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Required Intervention EXTRANEAL, PHYSIONEAL