BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2103049 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06501
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BAXTER HEALTHCARE SET, ADMINISTRATION, FOR PERITON
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE IS UNKNOWN. THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG, 4 LITERS (DOSE AND FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP), FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. LABORATORY RESULTS AND ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. THE OUTCOME AND ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 ULTRABAG