BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2152665 · Received June 24, 2011

    Report

    Report Number
    9615050-2011-00453
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 26, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    Z-1895-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED TESTING BY APPROPRIATELY ALARMING WHEN AIR WAS PRESENT IN THE TUBING DISTAL TO THE PUMP. THIS PUMP HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATED THAT ON (B)(6) 2011 AT 0210, CH A WAS PROGRAMMED IN THE BASIC MODE, USING THE DRUG LIBRARY TO DELIVER PROPOFOL 100ML, DOSE OF 40MCG/KG/MIN, AT A RATE OF 21.6ML/HR, A VTBI (VOLUME TO BE INFUSED) 3ML, FOR A DURATION OF 9 MINS, AIR IN LINE SETTING 500MCL, AND THE INFUSION WAS STARTED. BETWEEN 0210 AND 1728, THE DOSE, RATE, VTBI (LARGEST VOLUME WAS 95ML) AND DURATION WERE CHANGED 12 TIMES. CH A IS PLACED IN STANDBY MODE FROM 0430 TO 0827, WHEN THE BASIC PROGRAM IS RESUMED. AT 0827, THE INFUSION WAS STOPPED, THE CASSETTE EJECTED, CHECK CASSETTE ALARM, CASSETTE LOADED, CHECK CASSETTE ALARM CLEARED, INFUSION RESUMED, STOPPED, CHECK FLOWSTOP ALARM, ALARM SILENCED, CASSETTE EJECTED, CHECK FLOWSTOP ALARM CLEARED, CASSETTE LOADED AND INFUSION RESUMED. AT 1134, THE BASIC PROGRAM IS STOPPED, CASSETTE EJECTED, CHECK CASSETTE ALARM, CASSETTE LOADED, CHECK CASSETTE ALARM CLEARED, AND INFUSION IS RESUMED. AT 1206, THE INFUSION IS STOPPED, CHECK FLOWSTOP ALARM, ALARM SILENCED, CASSETTE EJECTED, CHECK FLOWSTOP ALARM CLEARED, CHECK CASSETTE ALARM, CASSETTE LOADED, CHECK CASSETTE ALARM CLEARED AND INFUSION RESUMED AT 10.8ML/HR. AT 1222, THE RATE WAS CHANGED TO 16.2ML/HR. AT 1346, AND END OF INFUSION ALARM OCCURS AND KVO DELIVERY BEGAN. AT 1353, END OF INFUSION ALARM WAS CLEARED, STOP KVO DELIVERY, THE VTBI WAS REPROGRAMMED FOR 2ML, FOR A DURATION OF 8 MIN, AND INFUSION WAS STARTED. AT 1401, END OF INFUSION ALARM AS OCCURRED, KVO DELIVERY BEGAN, STOP KVO DELIVERY, REPROGRAMMED A VTBI OF 95ML, FOR A DURATION OF 5 HOURS, 52 MIN AND INFUSION WAS STARTED. AT 1401, THE INFUSION WAS STOPPED, CASSETTE EJECTED, CHECK FLOWSTOP ALARM, ALARM SILENCED, CASSETTE EJECTED, AND CHECK FLOWSTOP ALARM CLEARED, CHECK CASSETTE ALARM, CASSETTE LOADED, CHECK CASSETTE ALARM CLEARED AND INFUSION WAS STARTED. AT 1404, THE INFUSION IS STOPPED, CH A IS PLACED ON STANDBY MODE FOR 30 SECONDS AND INFUSION IS STARTED. BETWEEN 1407 AND THE NEW DAY STAMP ON (B)(6) 2011 AT 1728, THERE ARE TWO CHANGES IN THE DOSE, RATE, VTBI AND DURATION. AT 1802, A USING BATTERY ALARM OCCURRED. AT 1820, USING AC ALARM OCCURRED. A REVIEW OF THE HISTORY FOUND THE PUMP DELIVERED AS PROGRAMMED. 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 AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PROPOFOL, WITH A 100ML VTBI (VOLUME TO BE INFUSED) AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT INDICATED THAT THE CONTAINER SIZE WAS 100ML. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PUMP ALARMED FOR END OF INFUSION. AT THAT TIME, THE NURSE REPORTED CONTAINER WAS EMPTY AND AIR WAS NOTED 6-8 INCHES PAST CASSETTE. IT WAS REPORTED NO AIR REACHED THE PATIENT. THE PUMP WAS REMOVED FROM CLINICAL USE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 UNK SYMBIQ TUBING SET: LIST #16005, LOT #UNK