BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3131821 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13510
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 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). 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. THE EXACT AGE AT THE TIME OF THE EVENT IS UNKNOWN. HOWEVER, THE PATIENT WAS BORN IN 1950.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER TREATMENT, THE PATIENT RECOVERED FROM PERITONITIS.(B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMEN PAIN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. THE PATIENT HAD NOT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235643 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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