BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4107268 · Received September 22, 2014

    Report

    Report Number
    1416980-2014-32624
    Event Type
    Injury
    Date Received
    September 22, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, AFTER SUBCUTANEOUS PATHWAY DIVERSION AND AFTER THE PATIENT¿S PD CATHETER WAS REMOVED, THE PERITONITIS WAS RESOLVING AND THE PATIENT WAS RECOVERING. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED ON HEMODIALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: OSHIO M, FUJII T, FUJII T, KUSAURA T. THREE CASES OF ELDERLY PATIENTS THAT WE INTRODUCED PERITONEAL DIALYSIS. KIDNEY AND DIALYSIS 2014; 77(S): 237-238. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE DUE TO AN INTERNAL ISSUE; HOWEVER, THIS COULD NOT BE MEDICALLY CONFIRMED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE EVENT. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED REFRACTORY PERITONITIS. TREATMENT FOR THE PERITONITIS EVENT WAS INSERTING A SUBCUTANEOUS PATHWAY DIVERSION (SPD). ON AN UNREPORTED DATE, THE PATIENT¿S (PD) CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS (HD) THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588338 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DIANEAL-N PD 1.5, EXTRANEAL| MINI CAP, TITANIUM ADAPTER