BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL W/FILTERTEK VALVE

    MDR report key: 2437944 · Received January 16, 2012

    Report

    Report Number
    9615050-2012-00071
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 21, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER. THE POSSIBLE LOT NUMBER IS 081595H. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY TUBING SET INTO THE PRIMARY TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, A MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET, FOR PIGGYBACK DELIVERY OF CLEOCIN 600MG/50ML, AT A RATE OF 100ML/HR. IT WAS REPORTED THAT THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. THE CUSTOMER CONTACT INDICATED THAT AFTER THE DELIVERY WAS STARTED, THE NURSE NOTED A "FAST RATE" IN THE DRIP CHAMBER OF THE SECONDARY TUBING SET AND THE FLUID LEVEL IN THE DRIP CHAMBER OF THE PRIMARY TUBING SET WAS REPORTEDLY FILLING. THE PRIMARY TUBING SET WAS REPLACED AND THERAPY WAS RESUMED. 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM SET 2 CL W/FILTERTEK VALVE UNK FPA HOSPIRA COSTA RICA LTD NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SECONDARY TUBING SET| LIST #UNK, LOT #UNK| SYMBIQ PUMP, LIST #UNK, SN UNK