BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4965846 · Received August 4, 2015

    Report

    Report Number
    1416980-2015-31408
    Event Type
    Injury
    Date Received
    August 4, 2015
    Report Date
    July 16, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). LUBIS, A.R.,LATIF, R.A. ¿PERITONEAL FISTULA DUE TO RECURRENT PERITONITIS IN CAPD PATIENTS.¿ PERITONEAL DIALYSIS INTERNATIONAL, 30 (JULY 2010): 426-428 (S101). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: IT WAS REPORTED THAT THERE IS NO BAXTER HEALTHCARE PRODUCT INVOLVED IN THIS REPORT AND THEREFORE THE BAXTER HEALTHCARE PRODUCT IS NO LONGER SUSPECT FOR THE PREVIOUSLY REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY DEVELOPED A PERITONEAL FISTULA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE CAUSE OF THE PERITONEAL FISTULA WAS DUE TO REPEATED (UNSPECIFIED NUMBER) PERITONITIS EVENTS. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS NOT REPORTED. ON AN UNREPORTED DATE, UNSPECIFIED DIANEAL THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS MODALITY. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507900 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other