BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM 2 CL W/FILTERTEK VALVE

    MDR report key: 2478564 · Received February 21, 2012

    Report

    Report Number
    9615050-2012-00143
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K103344. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR A PIGGYBACK DELIVER OF 250ML OF VINBLASTINE. IT WAS REPORTED THAT AFTER THE PIGGYBACK WAS COMPLETE, THE NURSE DELIVERED 20ML OF NORMAL SALINE INTO THE SECONDARY SOLUTION CONTAINER THROUGH A NEEDLELESS VALVE CONNECTOR. THE CUSTOMER CONTACTED INDICATED THAT THE NURSE RESTARTED THE DELIVERY USING THE SYMBIQ PUMP. AT THIS TIME, IT WAS REPORTED THAT NO FLOW OF SOLUTION WAS NOTED. IT WAS REPORTED THAT THE DELIVERY WAS STOPPED AND THE TUBING SET REMOVED FROM THE PUMP. THE CUSTOMER CONTACT INDICATED THAT THE NURSE THEN REPORTEDLY FLUSHED 20ML OF NORMAL SALINE INTO THE DISTAL CLAVE Y-SITE, UP THROUGH THE TUBING SET CASSETTE INTO THE SECONDARY CONTAINER, AND PLACED THE TUBING SET BACK INTO THE PUMP. IT WAS REPORTED THAT DELIVERY WAS RESTARTED AND SOLUTION FLOWED THROUGH THE TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM 2 CL W/FILTERTEK VALVE UNK FPA HOSPIRA COSTA RICA LTD. NA 091305H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING SET: LIST #14230, LOT # UNK| PHASEAL NEEDLELESS VALVE CONNECTOR:| MFR CARMEL PHARMA