BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3912945 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21461
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT AGE: THE PATIENT WAS BORN ON AN UNREPORTED DATE IN 1984. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTIC(S) (MEDICATION, DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. TWENTY-SIX DAYS AFTER HOSPITALIZATION STARTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391875 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% AND 2.5% PD4 ULTRABAGS