BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2191393 · Received July 27, 2011

    Report

    Report Number
    9615050-2011-00576
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE HISTORY INDICATED THAT ON (B)(6) 2011 AT 1136, CH B WAS PROGRAMMED FOR BASIC DELIVERY OF PACLITAXEL 324MG/586ML, AT A RATE OF 100ML/HR, A 586ML VTBI (VOLUME TO BE INFUSED), PROGRAMMING WAS CONFIRMED AND DELIVERY WAS STARTED. BETWEEN 1141 AND 1142, THE RATE WAS CHANGED TO 202ML/HR AND THE TIME TO 2HR 52 MIN, THE PROGRAM WAS STOPPED, CONFIRMED AND DELIVERY WAS RESTARTED. BETWEEN 1145 AND 1438, THE DEVICE ALARMED FOR AIR IN LINE 11 TIMES, DISTAL OCCLUSION 7 TIMES, CHECK CASSETTE 4 TIMES AND PROXIMAL OCCLUSION 3 TIMES. AFTER EACH ALARM, THE ALARMS WERE SILENCED, CLEARED AND THE DELIVERY WAS RESTARTED. AT 1452, THE DEVICE ALARMED END OF INFUSION, THE DEVICE INDICATED 586ML WAS DELIVERED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PT RECEIVED LESS MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PACLITAXEL, WITH A 568ML VTBI (VOLUME TO BE INFUSED), FOR A DURATION OF 3 HOURS, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE DEVICE DISPLAYED 568ML WAS DELIVERED; HOWEVER, APPROX 250ML REMAINING IN THE CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED AND COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1