BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHAN I

    MDR report key: 3894474 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-02996
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 27, 2014
    Manufacturer
    HOSPIRA HOLDINGS COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED THAT ON (B)(6) 2014 AT 1048, THE DEVICE WAS PROGRAMMED USING THE DRUG LIBRARY TO DELIVER HEPARIN DVT/PE INFUSION 25000UNITS/500ML, AT A RATE OF 31ML/HR, VTBI OF 500ML, FOR A CALCULATED DURATION OF 16HRS8MIN, WITH A KVO (KEEP VEIN OPEN) OF 5ML/HR AND DELIVERY WAS STARTED. BETWEEN 1416 AND 1732, A LOW BATTERY ALARM OCCURRED AND WAS CLEARED, THE SHIFT TOTAL WAS CLEARED, A DEPLETED BATTERY ALARM OCCURRED, CLEARED AND USING AC POWER IS INDICATED, THE DELIVERY WAS STOPPED AND INDICATED A VOLUME INFUSION OF 95.174 ML, CHECK CASSETTE ALARM OCCURRED AND WAS CLEARED. BETWEEN 1734 AND 1816, RESUME BASIC PROGRAM, AIR IN LINE ALARM OCCURRED AND WAS CLEARED THREE TIMES, BASIC PROGRAM WAS STOPPED AND WAS CLEARED, A CHANNEL CALLBACK ALARM OCCURRED AND WAS CLEARED TWICE. A NEW DATE STAMP FOR (B)(6) 2014 OCCURRED. BETWEEN 0138 AND 0310, A LOW BATTERY ALARM OCCURRED TWICE AND WAS CLEARED ONCE, END OF DELIVERY ALARM OCCURRED AD WAS CLEARED, BEGIN KVO DELIVERY, AND DELIVERY WAS STOPPED. AT 0312, A VTBI OF 250ML WAS PROGRAMMED, FOR A CALCULATED DURATION OF 8HR 4 MINS AND DELIVERY WAS STARTED. AT 1103, AN END OF INFUSION ALARM OCCURRED. AT 1104, A VTBI OF 100ML WAS PROGRAMMED, FOR A CALCULATED DURATION OF 2HRS52MINS AND THE DELIVERY WAS STARTED. AT 1227, THE DELIVERY WAS STOPPED. AT 1229, STANDBY MODE WAS ENTERED. AT 1343, THE DEVICE WAS POWERED OFF. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE 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 REPORTER THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON (B)(6) 2014 AT 1048, THE DEVICE WAS PROGRAMMED, USING THE DRUG LIBRARY, TO DELIVER HEPARIN 25,000 UNITS/500ML, AT A RATE OF 31ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 500ML FOR A DURATION OF 16HRS AND DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2014 AT APPROXIMATELY 0300, THE CUSTOMER REPORTED THE DEVICE ALARMED WITH AN END OF INFUSION ALARM. AT THAT TIME, IT WAS REPORTED THERE WAS APPROXIMATELY 250ML REMAINING IN THE CONTAINER INSTEAD OF A REPORTED SEVERAL ML. IT WAS UNSPECIFIED IF THE DEVICE WAS REMOVED FROM CLINICAL SERVICE OR IF THERAPY WAS CONTINUED USING A REPLACEMENT DEVICE. THE CUSTOMER CONTACT REPORTED THE HEPARIN DOSAGE WAS INCREASED BASED ON UNSPECIFIED BLOOD TEST RESULTS. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED ALL TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252547 SYMBIQ SINGLE CHAN I 80FRN FRN HOSPIRA HOLDINGS COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK