BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 3180257 · Received June 13, 2013

    Report

    Report Number
    9615050-2013-01628
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. THE DATES AND PROGRAMMING PRESENT IN THE DEVICE HISTORY DID NOT CORRELATE WITH THE CUSTOMER'S REPORTED SETTINGS AND EVENT INFORMATION. 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 THE DEVICE DID NOT ALARM WHEN THE TUBING WAS CLAMPED DISTAL TO THE DEVICE. ON (B)(6) 2013 AT 1400, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF LIPIDS, AT A RATE OF 1.7 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 6.8 ML, AND THE DELIVERY WAS STARTED. ON (B)(6) 2013 AT 0330, THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED FOR AN UNSPECIFIED "MOTOR MALFUNCTION." AT THAT TIME, THE NURSE NOTED THAT "CAIR" ON THE TUBING SET WAS IN THE CLOSED POSITION. THE NURSE REPORTED THE TUBING SET WAS BULGING AND FLUID WAS BACKING UP INTO THE CASSETTE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE AND THE TUBING SET WAS DISCARDED. THE CUSTOMER CONTACT REPORTED THE PATIENT'S GLUCOSE AND HYDRATION STATUS WERE MONITORED FOR AN UNSPECIFIED LENGTH OF TIME. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE DELIVERY WAS COMPLETED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269190 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ TUBING SET: LIST #(B)(4), LOT #UNK