BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 2772254 · Received October 2, 2012

    Report

    Report Number
    9615050-2012-01163
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 23, 2012
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A DELAY IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TPN (TOTAL PARENTERAL NUTRITION) AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE ALARMED FOR AIR IN LINE. AT THAT TIME, IT WAS REPORTED THAT THE NURSE NOTED AN UNSPECIFIED AMOUNT OF LITTLE BUBBLES OF AIR IN THE TUBING. THE DELIVERY WAS STOPPED AND THE NURSE REMOVED THE AIR FROM THE TUBING. THERAPY WAS RESUMED USING THE SAME DEVICE. THE NURSE REPORTED THAT NO AIR REACHED PATIENT. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ TUBING SET, LIST #UNK, LOT #UNK