BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3901994 · Received May 7, 2014

    Report

    Report Number
    9615050-2014-03276
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    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
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED CH A OF THE DEVICE WAS PROGRAMMED AND CONFIRMED ON (B)(4) 2014 AT 1615 TO DELIVER TPN AT A RATE OF 11 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 200ML AND THE DELIVERY WAS STARTED. CH B WAS OF THE DEVICE WAS PROGRAMMED TO DELIVERY MORPHINE 1MG/ML, A 4.4 KG WT WAS PROGRAMMED, WITH A DOSE RATE OF 0.1MG/KG/HR, AND A VTBI OF 25ML AND THE DELIVERY WAS STARTED. A NEW DATE OF (B)(4) 2014 OCCURRED. AT 0450 CH A AND CHB THE DELIVERIES WERE STOPPED AND STANDBY MODE WAS ENTERED. AT 0455, STANDBY MODE ON CHA AND CHB WAS CANCELLED. AT 0544, A LOW BATTERY ALARM OCCURRED. AT 0546, THE DEVICE INDICATED AC POWER AND THE LOW BATTERY ALARM WAS CLEARED AND THE BATTERY CHARGE BEGAN. AT 0802, A S132 (SYSTEM VOLTAGE CURRENT) MALFUNCTION ALARM OCCURRED ON CHA AND CHB AND THE DEVICE POWERED OFF. AT 0803, THE DEVICE WAS POWERED ON. AT 0804, THE DEVICE WAS POWERED OFF. 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 THAT THE DEVICE POWERED OFF BY ITSELF WITH INADEQUATE RESPONSE TIME FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER TPN (TOTAL PARENTERAL NUTRITION) AND THE DELIVERY WAS STARTED. ON AN UNSPECIFIED DATE AND TIME, THE OTHER CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH A CONSTANT S132 (SYSTEM VOLTAGE-UIC) MALFUNCTION ALARM CODE AND POWERED OFF BY ITSELF. THERE WAS A REPORTED DELAY IN THERAPY; HOWEVER, WERE NO REPORTS OF ANY ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S132 MALFUNCTION ALARM CODE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276827 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK