BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 2122051 · Received May 24, 2011

    Report

    Report Number
    9615050-2011-00377
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 29, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    Z-1894-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING BY APPROPRIATELY ALARMING WHEN AIR WAS PRESENT IN THE TUBING DISTAL TO THE PUMP. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THE PUMP HISTORY DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THIS HISTORY FOUND ON (B)(4) 2011 AT 0856 CH A WAS PROGRAMMED IN THE BASIC MODE VIA DRUG LIBRARY TO INFUSE MAINTENANCE IVF 1000ML, AT A RATE OF 10ML/HR, VTBI 20ML, FOR A DURATION OF 2 HRS, DELIVER AT END OF INFUSION SETTING: KVO RATE OF 1ML/HR, INFUSION COMPLETE CALLBACK SETTING: NO, AIR IN LINE SETTING 250MCL, NEARING END OF INFUSION SETTING OFF AND THE INFUSION WAS STARTED. AT 0104, PIGGYBACK MODE ACCESSED, HANG SECONDARY CONTAINER HIGHER CONFIRMED, BASIC PROGRAM WAS STOPPED, A PIGGYBACK WAS PROGRAMMED VIA THE DRUG LIBRARY TO DELIVER VANCOMYCIN 400MG/100ML, AT A RATE OF 50ML/HR, VTBI 98ML, FOR A DURATION OF 1 HR 58MIN, INFUSION COMPLETE CALLBACK SETTING YES, AIR IN LINE SETTING 250MCL AND THE INFUSION WAS STARTED. AT 0105, THE BASIC PROGRAM ACCESSED, CONFIRMED THE BASIC DELIVERY WILL START WHEN THE PIGGYBACK COMPLETES. AT 0105, THE PIGGYBACK MODE WAS ACCESSED AND CALLBACK WAS DEACTIVATED. BETWEEN 0255 AND 0257, THE PIGGYBACK RATE, DURATION AND VTBI WERE CHANGED, HANG SECONDARY CONTAINER HIGHER WAS CONFIRMED AND THE PIGGYBACK WAS RESUMED. AT 0305, THE PIGGYBACK DELIVERY ENDED AND THE BASIC PROGRAM RESUMED. AT 0316, THE PIGGYBACK MODE WAS ACCESSED, HANG SECONDARY CONTAINER HIGHER CONFIRMED, BASIC PROGRAM WAS STOPPED, A PIGGYBACK WAS PROGRAMMED, AT A RATE OF 100ML/HR, VTBI 48ML, FOR A DURATION OF 29 MINUTES AND PIGGYBACK DELIVERY WAS STARTED. AT 0344, THE PIGGYBACK DELIVERY ENDS AND THE BASIC PROGRAM WAS RESUMED. AT 0444, AN AIR IN LINE ALARM OCCURS FOR A 15 MINUTE ACCUMULATION OF 1ML (THE ACCUMULATED AIR THRESHOLD IS 1ML) AND BASIC PROGRAM IS STOPPED. BETWEEN 0445 AND 0451, THE ALARM IS SILENCED 4 TIMES, THE ALARM RESUMED EVERY 2 MINUTES, THE CASSETTE WAS EJECTED AND THE PUMP WAS POWERED OFF. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE PUMP WITH NO PUMP ALARM. THE DEVICE WAS PROGRAMMED FOR BASIC DELIVERY OF NORMAL SALINE AT A RATE OF 10ML/HR. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED ANTIBIOTIC, WITH A RATE OF 100ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 48ML, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT THE PIGGYBACK CONTAINER WAS HUNG HIGHER THAN THE PRIMARY CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE WENT TO THE PT'S ROOM TO CHECK ON AN UNSPECIFIED ALARM CONDITION. AT THAT TIME, CUSTOMER CONTACT REPORTED, THE DEVICE WAS ALARMING FOR AIR IN LINE. IT WAS REPORTED THAT THE PIGGYBACK CONTAINER WAS EMPTY AND AIR NOTED DISTAL IN THE TUBING DISTAL TO THE PUMP, 2CM PROXIMAL TO THE AIR ELIMINATING FILTER. AT THIS TIME, THE DISPLAY INDICATED, THE BASIC DELIVERY HAD RESUMED; HOWEVER, THE DEVICE WAS "PULLING AIR FROM THE PIGGYBACK." IT WAS REPORTED THAT NO AIR REACHED THE PT. THE PUMP WAS REMOVED FROM CLINICAL USE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP AND TUBING SET. 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR SYMBIQ TUBING SET: LIST #16021, LOT # UNK