BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4240564 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39694
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE FOLLOWING MONTH, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH FORTAZ INTRAVENOUSLY (IV, DOSE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE SAME MONTH AS ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. AFTER DISCHARGE, THE PATIENT WAS TREATED WITH FORTAZ, INTRAPERITONEALLY (IP, DOSE AND FREQUENCY WERE UNKNOWN) FOR PERITONITIS. THE (PDRN) STATED THAT THE ¿PATIENT HAD PERITONITIS ON AND OFF¿ FOR THE PAST MONTH. IN THE SAME MONTH AS THE INITIAL HOSPITALIZATION FOR PERITONITIS, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR RECURRENT PERITONITIS. IT WAS REPORTED BY THE PDRN THAT THE PATIENT HAD NEVER RECOVERED FROM THE INITIAL PERITONITIS EVENT AND HAD BEEN ON ANTIBIOTICS FOR 2 MONTHS. THE CAUSE OF THE RECURRENT PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR RECURRENT PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED IN THE HOSPITAL AND WAS RECOVERING FROM THE PERITONITIS EVENT. PD WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 4 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723946 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTENSION SET, HOMECHOICE,| 2.5% DIANEAL PD4 ULTRABAG| 1.5% DIANEAL PD4 AMBUFLEX,| 2.5% DIANEAL PD4 AMBUFLEX| TITANIUM ADAPTER, MINICAP, CASSETTE,