BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD SOLUTION TRANSFER SET FOR UV-FLASH

    MDR report key: 850608 · Received May 1, 2007

    Report

    Report Number
    1423500-2007-00161
    Event Type
    Injury
    Date Received
    May 1, 2007
    Date of Event
    April 5, 2007
    Report Date
    April 6, 2007
    Manufacturer
    MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER'S PRODUCT SURVEILLANCE DEPT IS PURSUING ADD'L INFO REGARDING THIS INCIDENT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    A BAXTER COMPLAINT COORDINATOR FROM ANOTHER COUNTRY REPORTED AN ADVERSE EVENT OCCURRED DURING A PD TREATMENT. THE PT CONTACTED THE HOSP TO REPORT AN ABDOMINAL PAIN AND WAS HOSPITALIZED BECAUSE PERITONITIS WAS SUSPECTED. THE UV TRANSFER SET HAS BEEN REPLACED AT THE HOSP. THE PHARMACIST REPORTED THAT THE PERITONITIS WAS RELATED TO A PROBLEM WITH THE UV TRANSFER SET, SINCE THE PT HAD BEEN UNABLE TO CLEAN FLUSH (UV FLUSH) THE SET BECAUSE THE TUBING WAS KINKED. THE UV TRANSFER SET HAD BEEN IN PLACE ONE MONTH PRIOR TO THE DATE OF EVENT. THE FOLLOWING DRUGS WERE USED. DIANEAL N PD-4 UV TWIN 1.5% 2 L BAG, DIANEAL N PD-4 UV TWIN 2.5% L BAG, EXTRANEAL 2 L BAG. OTHER DRUGS USED WERE SARPOGRELATE HCL AND BIOFERMIN. NO OTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD SOLUTION TRANSFER SET FOR UV-FLASH UV TRANSFER SETS KDJ MOUNTAIN HOME T5C4325 H07A30040

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization