BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 1 CHANNEL V2.

    MDR report key: 2193094 · Received July 22, 2011

    Report

    Report Number
    9615050-2011-00557
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. A REVIEW OF THE HISTORY ON (B)(6) 2011 AT 0829, THE DEVICE WAS PROGRAMMED AND CONFIRMED FOR MULTISTEP THERAPY OF IVIG (B)(6), NUMBER OF STEPS 5, DELIVER AT END OF INFUSION SETTING KVO RATE OF 1.1ML/HR, INFUSION CALLBACK YES, STEP 1 RATE 54ML/HR, WITH A 27ML VTBI FOR A DURATION OF 30MINS, STEP 2 RATE 108ML, WITH A VTBI OF 54, FOR A DURATION OF 30MINS, STEP 3 RATE 162ML/HR, WITH A 81ML VTBI, FOR A DURATION OF 30MINS, STEP 4 RATE 216ML, WITH A 216ML VTBI, FOR A DURATION OF 1HR, STEP 5 RATE 216ML, WITH A 45ML VTBI, FOR A DURATION OF 13MINS AND THE DELIVERY WAS STARTED. AT 0859, STEP 1 COMPLETED AND AN END MULTISTEP STEP DELIVERY ALARM OCCURRED AND WAS CLEARED. AT 0909, STANDBY MODE ENTERED AND STEP 2 DELIVERY STOPPED, 18.967ML VOLUME DELIVERED. AT 0942, STANDBY MODE CANCELLED, RESUME STEP 2 DELIVERY AND THE DELIVERY WAS STOPPED. AT 0943, A 1.8ML VTBI WAS PROGRAMMED FOR STEP 2, THE PROGRAMMING IS CONFIRMED AND THE DELIVERY IS STARTED. AT 0944, STEP 2 DELIVERY IS COMPLETE AND A MULTISTEP STEP COMPLETE ALARM OCCURRED AND CLEARED. AT 0945, THE STEP 3 OF DELIVERY IS STOPPED. AT 0946, STEP 3 DELIVERY IS RESUMED. BETWEEN 0950 AND 0953, THE DELIVERY IS STOPPED, THE VOLUME DELIVERED FOR STEP 3 WAS 13.315ML, THE CASSETTE IS EJECTED, STANDBY MODE ENTERED AND CANCELLED, A CALLBACK ALARM OCCURRED. BETWEEN 0954 AND 1003, 4 CHECK CASSETTE ALARMS OCCURRED, SILENCED 6 TIMES AND RESUMED 4 TIMES. AT 1004, 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 THE DEVICE DID NOT DELIVER. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED FOR THE MULTISTEP THERAPY, TO DELIVER IVIG (INTRAVENOUS IMMUNOGLOBULIN) 500ML, AT A MAXIMUM RATE 240ML/HR, WITH A 450ML VTBI (VOLUME TO BE INFUSED), INFUSION COMPLETE ALARM SELECTED AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE DID NOT ALARM AT THE COMPLETION OF STEP 2 AND STEP 3 DID NOT BEGIN AS EXPECTED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ 1 CHANNEL V2. 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR