BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2062324 · Received March 18, 2011

    Report

    Report Number
    9615050-2011-00170
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A F/U 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AMIODARONE 450MG/450ML, AT THE RATE 60ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED FOR AIR IN LINE. AT THAT TIME, THE NURSE NOTED THERE WAS NO AIR NOTED IN THE TUBING. THE CUSTOMER CONTACT REPORTED THAT OVER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED "AT LEAST" 8 TIMES FOR AIR IN LINE WITH NO AIR NOTED IN THE TUBING. THE CUSTOMER CONTACT REPORTED THE VTBI (VOLUME TO BE INFUSED) WAS REPORTEDLY "OFF" BY 30ML DUE TO THE DELAY; HOWEVER, THE EXPECTED VTBI WAS UNSPECIFIED. THE DEVICE WAS REMOVED FROM CLINICAL USE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE, USING THE SAME TUBING SET. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT REPORTED THE PT'S STATUS WAS UNCHANGED. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO 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 74 YR SYMBIQ PUMP SET: LIST #16019, LOT# UNK