BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 1915344 · Received November 3, 2010

    Report

    Report Number
    2921482-2010-00855
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 6, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNSPECIFIED CLINICAL AREA WITH A NOTE THAT STATED, "FAILED TO DETECT AIR IN LINE." ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VANCOSAMINE. NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF AIR IN THE TUBING SET DISTAL TO THE PUMP WITH NO PUMP ALARM. THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFO, INCLUDING PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK