BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3131681 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13588
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 6, 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). 'THE PATIENT'S BIRTH DATE IN 'THIS EVENT IS UNKNOWN. HOWEVER IT WAS INDICATED THAT THE PATIENT WAS BORN IN 1982. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. 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 HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT WAS TREATED WITH CEFAZOLIN 2 GRAM (G)/DAY, INTRAPERITONEAL INJECTION (IP) AND GENTAMYCIN 80 MILLIGRAM(MG)/DAY, IP FOR PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLIN 2 G/DAY, IP AND GENTAMYCIN 80 MG/DAY, IP FOR PERITONITIS. TWELVE DAYS LATER, CEFAZOLIN AND GENTAMYCIN WERE STOPPED. ON THE THIRTEENTH DAY, THE PATIENT WAS TREATED WITHVANCOMYCIN 1 G/DAY, IP AND AMIKACIN 300 MG/DAY, IP FOR PERITONITIS. TWENTY SEVEN DAYS AFTER HOSPITAL ADMISSION, THE VANCOMYCIN AND AMIKACIN WERE STOPPED AND THE PATIENT WAS DISCHARGED. THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235978 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5% AND DIANEAL PD4 2.5%