BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 2992394 · Received March 1, 2013

    Report

    Report Number
    9615050-2013-00314
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. A REVIEW OF THE DEVICE HISTORY INDICATED ON (B)(6) 2013 AT 2356, CHANNEL A OF THE DEVICE WAS PROGRAMMED USING THE DRUG LIBRARY TO DELIVER LEVOPHED 4MG/500ML, AT A RATE OF 20MCG/MIN, WITH A VTBI OF 400ML, AND THE DELIVERY WAS STARTED. ON (B)(6) 2013 BETWEEN 0033 AND 0121, 3 AIR IN LINE ALARMS OCCURRED AN WERE CLEARED. AT 0122, A TITRATED RATE OF 15MCG/MIN WAS PROGRAMMED. AT 0132, A TITRATED RATE OF 20MCG/MIN WAS PROGRAMMED. AT 0145, A TITRATED RATE OF 15MCG/MIN WAS PROGRAMMED. AT 0214, 2 AIR IN LINE ALARMS OCCURRED AND WERE CLEARED. AT 0241, A TITRATED RATE OF 10MCG/MIN WAS PROGRAMMED. AT 0300, AN AIR IN LINE ALARM OCCURRED AND WAS CLEARED. AT 0310, KVO DELIVERY BEGAN. AND AN END OF INFUSION ALARM OCCURRED, KVO DELIVERY STOPPED AND DELIVERY WAS STARTED. AT 0340, A VTBI OF 40ML WAS PROGRAMMED AND THE DELIVERY WAS STARTED. AT 0402, AN END OF INFUSION ALARM OCCURRED, KVO DELIVERY BEGAN A VTBI OF 40ML WAS PROGRAMMED AND THE DELIVERY STARTED. BETWEEN 0421 AND 0427, AN END OF INFUSION ALARM OCCURRED AND CLEARED, KVO DELIVERY BEGAN, STANDBY MODE ENTERED, KVO DELIVERY STOPPED, CASSETTE EJECTED, A CHECK CASSETTE ALARM OCCURRED AND WAS CLEARED, A CASSETTE LOADED, STANDBY MODE CANCELED, KVO DELIVERY RESUMED. AT 0427, A TITRATED RATE OF 10MCG/MIN WAS PROGRAMMED, THE NEXT BUTTON WAS PRESSED, THE DELIVERY WAS STOPPED, KVO DELIVERY WAS STOPPED. THE NEXT POWER ON WAS INDICATED ON (B)(6) 2013 AT 0847, A POST SOFTWARE S308 (CAN BUS ERROR-PMC, A), POST SOFTWARE ALARM TIGHT LOOP MALFUNCTION AND CASSETTE EFFECT LEVER ALARM OCCURRED. 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 A WHITESCREEN ERROR. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF LEVOPHED, AT A RATE OF 15MCG/MIN AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2013 AT APPROXIMATELY 0330, THE CUSTOMER INDICATED A NEW CONTAINER OF MEDICATION WITH A VOLUME OF 250ML WAS HUNG. AT 0426, THE DEVICE ALARMED FOR END OF INFUSION ALARM AND CHECK CASSETTE. AT APPROXIMATELY 0430, THE DEVICE DISPLAYED A WHITESCREEN ERROR WITH UNSPECIFIED ERROR CODES. AT THAT TIME, THE NURSE REPORTED THE DEVICE WAS INOPERABLE. IT WAS REPORTED THE NURSE USED THE EMERGENCY CASSETTE EJECT LEVER TO REMOVE THE TUBING SET FROM THE DEVICE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE NURSE INDICATED THAT FOR APPROXIMATELY 5 MINUTES, THE LEVOPHED WAS DELIVERED VIA GRAVITY. AT THAT TIME, THE CUSTOMER CONTACT REPORTED THE PT'S BLOOD PRESSURE DECREASED TO 60/30MMHG FROM THE PT'S BASELINE; HOWEVER, THE PT WAS REPORTED TO BE HYPOTENSIVE PRIOR TO THE WHITESCREEN ERROR. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PT'S BLOOD PRESSURE RETURNED TO THE UNSPECIFIED BASELINE LEVEL. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89114 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R LEVOPHED| SYMBIQ TUBING SET LIST