BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2801298 · Received October 17, 2012

    Report

    Report Number
    9615050-2012-01240
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. AT 1441, CHANNEL A OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ZOLEDRONATE-MANNITOL, AT A RATE OF 400 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 100 ML, FOR A DURATION OF 15 MINUTES, AND DELIVERY WAS STARTED. AT 1457, THE NURSE REPORTED THE PUMP ALARMED FOR END OF INFUSION AND BEGAN TO DELIVER AT AN UNSPECIFIED KVO (KEEP VEIN OPEN) RATE. AT THAT TIME, THE NURSE WENT TO THE PATIENT'S ROOM AND NOTED THE CONTAINER WAS EMPTY. IT WAS REPORTED THAT AIR WAS IN THE TUBING SET TO THE DISTAL PORT WITH NO PUMP ALARM. IT WAS REPORTED NO AIR WAS DELIVERED TO THE PATIENT. THE DEVICE WAS REMOVED FROM CLINICAL USE. THE CUSTOMER CONTACT REPORTED THE THERAPY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR SYMBIQ TUBING SET: LIST #16068-28, LOT #UNK