BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3061979 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09435
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 25, 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) FOLLOW-UP WAS RECEIVED FROM A NURSE. EIGHTEEN DAYS AFTER HOSPITALIZATION, THE PATIENT COMPLETED TREATMENT WITH CEFAZOLIN AND GENTAMYCIN. THAT SAME DAY, THE PATIENT RECOVERED FROM PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE PATIENT WAS TREATED WITH CEFAZOLINE (2GRAM/DAY INTERPERITONEAL (IP) AND GENTAMYCIN (80MILLIGRAM/DAY IP). THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163430 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL PD4 1.5%