BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2646403 · Received July 3, 2012

    Report

    Report Number
    2646403
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    May 10, 2012
    Report Date
    July 3, 2012
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    WHEN SWITCHING FLOLAN FROM UVC UMBILICAL VENOUS CATHETER TO PICC, PLACED AN NS NORMAL SALINE FLUSH BEHIND UVC FLOLAN TO CONTINUE THAT FLUSH WHILE FLOLAN INFUSION STARTING IN PICC. NOTED CRACK IN FILTER ON NS FLUSH AND INCREASING BP DUE TO FLUSH NOT INFUSING PROPERLY. BP DID NOT CAUSE PROBLEMS AND RESOLVED AFTER CHANGING LINE.======================MANUFACTURER RESPONSE FOR SYRINGE PUMP IV TUBING, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================KNOWN PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYRINGE PUMP IV TUBING FPA SMITHS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO