BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTED BASIC SOLUTION SET WITH .22 MICRON FILTER

    MDR report key: 18454 · Received December 16, 1994

    Report

    Report Number
    MW1004485
    Event Type
    Other
    Date Received
    December 16, 1994
    Date of Event
    November 30, 1994
    Report Date
    December 5, 1994
    Manufacturer
    IV SYSTEMS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TAXOL INFUSION WAS COMPLETED. NORMAL SALINE INFUSED FOR 2 HOURS. PT THEN GIVEN CISPLATIN OVER 30 MINUTES. THIS INFUSION WAS FOLLOWED BY NS HYDRATION FOR 2 HOURS. AFTER CISPLATIN INFUSED NURSE NOTICED A PRECIPITATION IN THE SECTION OF THE TUBING IN DIRECT CONTACT WITH THE PERISTALTIC ROLLERS OF THE PUMP. THE PUMP HAD NOT ALERTED THE NURSE OF A PROBLEM. NO ADVERSE EVENT WAS SEEN WITH THE PT AND A FILTER WAS USED SO DISLODGED PRECIPITANT WOULD NOT HAVE INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED BASIC SOLUTION SET WITH .22 MICRON FILTER FPA IV SYSTEMS DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other