BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3130309 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13387
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ASEPTIC PERITONITIS DUE TO PEPTIDOGLYCAN DURING THE FIRST EXCHANGE OF THE DAY NOT REQUIRING HOSPITALIZATION. THE PATIENT WAS ASYMPTOMATIC AND REMEDIAL MEDICATION WAS NOT REQUIRED. ON AN UNREPORTED DATE, EXTRANEAL WAS PERMANENTLY DISCONTINUED DUE TO THE PERITONITIS. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF SUSPECTED PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). IT WAS NOT REPORTED IF EXTRANEAL THERAPY WAS ONGOING. TREATMENT WAS NOT REPORTED. THE ROOT CAUSE OF THE SUSPECTED PERITONITIS WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231415 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ATENOLOL, MANIDIPINE, DOXAZOSIN GITS, ATORVASTATIN| ACETYLSALICYLIC ACID, LANTHANUM CARBONATE| CINACALCET, FOLIC ACID, EPOETIN| EXTRANEAL