BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3942451 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23085
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (PT) EXPERIENCED A CONNECTION ISSUE AND SUBSEQUENTLY EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE DUE TO THE PATIENT¿S MINI CAP FELL OFF OF THE PATIENT¿S TRANSFER SET WHILE THE PATIENT WAS CUTTING THE GRASS AND HE RE-CAPPED THE TRANSFER SET USING THE SAME MINI CAP. THREE DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT RECEIVED UNKNOWN ANTIBIOTICS IN HIS SOLUTIONS BAGS. TWO WEEKS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT AND PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419908 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL PD4 AMBUFLEX THERAPIES, HOMECHOICE| MINICAP