BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3953507 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23899
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUED TO PRESENT HYPEREOSINOPHILIA AND HAVE AN INCREASE OF EOSINOPHILS IN THE DIALYSATE. ADDITIONALLY, THE PATIENT CONTINUED TO PRESENT WITH CLOUDY EFFLUENT ALMOST EVERY DAY, OCCURRING OFTEN WITH THE FIRST DRAIN OF THE DAY. IT WAS ALSO REPORTED THAT THE PATIENT REMAINED ASYMPTOMATIC. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, CLOUDY EFFLUENT WAS REPORTED AFTER THE NIGHTLY EXCHANGE. AT THE TIME OF THIS REPORT, THE PATIENT'S PERITONEAL DIALYSIS PROTOCOL WAS NOT CHANGED AND WAS STILL PERFORMING THE THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, IT WAS REPORTED THAT THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430286 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR PHYSIONEAL 1.36%, NUTRINEAL, LASILIX, ARANESP| EUPRESSYL, FOSRENOL, HYPERIUM| ALLOPURINOL ALMUS, DETENSIEL, DUPHALAC, ENGERIX| DIETIC FOOD FOR DIALYSED PATIENTS