BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3830200 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16788
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS THE ONSET FOR THE PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. EIGHTEEN DAYS LATER, THE TREATMENT WITH ANTIBIOTICS WAS DISCONTINUED. NINE DAYS LATER, THE PATIENT WAS ADMITTED AGAIN TO HOSPITAL AS THE PATIENT STILL HAD PERITONITIS. ON THE SAME DAY, THE PATIENT AGAIN STARTED TREATMENT WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE TREATMENT WITH ANTIBIOTICS WAS ONGOING. THE PATIENT WAS STILL IN THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307635 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIANEAL 1.5%, 2.5%, AND 4.25%, EXTRANEAL| CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD)