BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4182965 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36415
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY DEHYDRATION AND CONSTIPATION. THE CAUSE OF THE PERITONITIS EVENT WAS BELIEVED TO BE CONSTIPATION; HOWEVER THIS COULD NOT BE MEDICALLY CONFIRMED. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL GENTAMYCIN (DOSE, ROUTE AND FREQUENCY UNKNOWN). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHIN FOUR DAYS OF ADMISSION. AT THE TIME OF DISCHARGE THE DEHYDRATION AND CONSTIPATION HAD BEEN RESOLVED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661773 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DIANEAL AMBUFLEX PD4 2.5%| DIANEAL AMBUFLEX PD4 1.5%| HOMECHOICE PRO| TITANIUM ADAPTER, MINICAP, CASSETTE