BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL W/FILTERTEK VALVE

    MDR report key: 2462742 · Received February 14, 2012

    Report

    Report Number
    9615050-2012-00123
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 18, 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
    MN, US
    Reporter Occupation
    OTHER

    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 BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVERY AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE OF THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF 100ML OF AN UNSPECIFIED CONCENTRATION OF CEPHAZOLIN. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT 10 MINS AFTER THE DELIVERY WAS STARTED, THE NURSE NOTED THAT SECONDARY SOLUTION STARTED, THE NURSE NOTED THAT THE SECONDARY SOLUTION CONTAINER WAS EMPTY. THE PUMP AND TUBING SET WERE REPLACED AND THE THERAPY WAS RESUMED. DURING TESTING AT THE USER FACILITY, BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER WAS NOTED. 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 SET 2 CL W/FILTERTEK VALVE UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

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