BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE/SPIKE PHARMACY SOLUTION CONNECTION SET

    MDR report key: 3381298 · Received September 3, 2013

    Report

    Report Number
    2025816-2013-00088
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION TO DATE: A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST#/SIMILAR PROBLEM RECORDED NO ADD'L REPORTS. A REVIEW OF THE MFG LOT DATABASE FOR THE TWO REPORTED SUSPECT LOT NUMBERS SHOWS LOT# 2473692 (MFG DATE 03/2012) (B)(4) UNITS WERE ALL MFG, TESTED, INSPECTED, AND RELEASED. CAUSE OF THE REPORTED INCIDENT IS UNK AT THIS TIME.

    Description of Event or Problem · 1

    INT'L ((B)(6)) COMPLAINT RECEIVED REPORTING MULTIPLE ISSUES WITH USE OF ONE (1) 011-H1922 17" CLAVE/SPIKE PHARMACY DRUG SOLUTION CONNECTION SET. IT WAS REPORTED THAT "...SET DIDN'T ALLOW THE START OF THE INFUSION OF THERAPY (TAXOL). TOUCHING THE OUTSIDE OF THE FILTER IT WAS STICKING AND IT SEEMED TO BE DUE TO THE DRUG CONTAMINATION. WHILE TRYING TO RESTART THE THERAPY, THERE WAS A LACK OF THE DRUG WHERE THE CLAVE IS ATTACHED AND THE CUSTOMER CAME INTO CONTACT WITH IT. AFTER CHANGING THE DEVICE THE THERAPY STARTED WITHOUT ANY PROBLEM. THIS ISSUE CAUSED A DELAY OF ABOUT 30 MINUTES IN ADMINISTRATION TO THE PT..." THERE WERE NO ADVERSE PT/OPERATOR CONSEQUENCES. ADD'L INFO, AND ACCESS TO THE DEVICE SET HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436435 CLAVE/SPIKE PHARMACY SOLUTION CONNECTION SET EXTENSION SET FPA ICU MEDICAL, INC. 011-H1922 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1