BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4251506 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40633
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). ON (B)(6) 2014, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR BACTERIAL PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMEN PAIN AND CLOUDY EFFLUENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNKNOWN ANTIBIOTICS FOR PERITONITIS. ON AN UNREPORTED DATE, THE CATHETER WAS REMOVED AS THE PATIENT DID NOT RESPOND TO THE PERITONITIS TREATMENT. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT THE PATIENT WAS NOT RECOVERED FROM THIS PERITONITIS EVENT. ON (B)(6) 2014, DIANEAL PD4 1.5% THERAPY WAS WITHDRAWN. ON AN UNREPORTED DATE, DIANEAL PD4 2.5% WAS WITHDRAWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT INFORMATION AND PATIENT OUTCOME WERE NOT REPORTED. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736692 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R MINICAP| DIANEAL PD4 2.5% SOLUTION| DIANEAL 1.5%| TRANSFER SET