BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3240840 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19303
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ON (B)(6) 2013, FOLLOW UP INFORMATION WAS OBTAINED RELATED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND HAD THEIR CATHETER REMOVED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH FORTUM (1MG), VANCOMYCIN (1MG) AND AMIKACIN (100MG) (ROUTE AND FREQUENCY NOT REPORTED). THE PATIENT WAS RECOVERING FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340967 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R DIANEAL 1.5% SINGLEBAG| DIANEAL PD2 2.5% ULTRABAG AND EXTRANEAL