BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4252339 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40791
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS NOT REPORTED. FIVE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. FIVE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PERITONITIS WAS RESOLVED, THE PATIENT WAS RECOVERED AND THE PATIENT WAS DISCHARGED. THE PATIENT PERFORMS BOTH AUTOMATED PERITONEAL DIALYSIS (APD) AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPIES. THE ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737423 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization TITANIUM ADAPTER, CASSETTE, MINICAP, HOMECHOICE| DIANEAL PD4, 1.5% & 2.5%, EXTRANEAL