BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET2 CL W/FILTERTEK VALVE

    MDR report key: 2652482 · Received July 5, 2012

    Report

    Report Number
    9615050-2012-00737
    Event Type
    Malfunction
    Date Received
    July 5, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 6, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED; HOWEVER, A REPRESENTATIVE DEVICE OF THE SAME LIST NUMBER FROM HOSPIRA STOCK WAS EVALUATED. THE DEVICE PASSED TESTING. NO BACKFLOW OF FLUID WAS NOTED. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE LIST NUMBER IN D4 HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K103344. THIS REPORT REPRESENTS ALL THE INFORMATION 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 SOLUTION CONTAINER INTO THE PRIMARY TUBING CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, 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 ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY TUBING CONTAINER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER AND IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM SET2 CL W/FILTERTEK VALVE UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

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