BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 2852237 · Received November 12, 2012

    Report

    Report Number
    9615050-2012-01329
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 15, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WOULD NOT BE RETURNED AT THIS TIME FOR TESTING AND INVESTIGATION. 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. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER 10% DEXTROSE IN WATER AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT AFTER LESS THAN 24 HOURS, THE NURSE REPORTED THE DEVICE ALARMED FOR PROXIMAL OCCLUSION; HOWEVER, NO OCCLUSION WAS PRESENT. THE NURSE UNSUCCESSFULLY ATTEMPTED TO RESOLVE THE ALARM CONDITION BY POWERING THE DEVICE ON AND OFF, RELOADING THE TUBING SET INTO THE DEVICE AND INCREASING THE HEIGHT OF THE DEVICE ON THE IV POLE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE CUSTOMER CONTACT INDICATED THE DELAY IN RESUMING THERAPY WAS APPROXIMATELY 15-25 MINUTES. 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 SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA, LTD NA NA

    Patients

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