BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2039011 · Received February 23, 2011

    Report

    Report Number
    9615050-2011-00105
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    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
    SD, 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 CATALOG NUMBER FOR THE SYMBIQ TUBING SET WAS NOT PROVIDED. THE SYMBIQ TUBING SET HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K041550. THIS REPORT REPRESENTS ALL THE INFORMATION 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 SYMBIQ PRIMARY TUBING SET WAS BEING USED TO DELIVER 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 ON THE SYMBIQ PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF ZOSYN 3.375GM/50ML AT A RATE OF 12.5ML/HR FOR A DURATION OF 4 HRS. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. THE CUSTOMER CONTACT REPORTED THAT IMMEDIATELY AFTER THE ZOSYN DELIVERY WAS STARTED, THE NURSE NOTED THAT THE MEDICATION "WAS RUNNING FASTER THAN THE PROGRAMMED RATE AND POTENTIALLY BACKING UP INTO THE PRIMARY BAG." THE DELIVERY WAS STOPPED. THE TUBING SETS WERE REPLACED AND THE 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

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