BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY SYMBIQ SET PIGGYBACK WITH BACK CHECK VALV

    MDR report key: 3893491 · Received June 13, 2014

    Report

    Report Number
    3893491
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MAIN IV D5.45NS/20 KCL WAS INFUSING THROUGH THE CENTRAL LINE ON A CABG (CORONARY ARTERY BYPASS GRAFT) PATIENT. RN HUNG A 1 GRAM CALCIUM CHLORIDE 60 CC RIDER AS A SECONDARY INFUSION TO THE MAIN IV. A FEW MINUTES LATER WHEN THE RN LOOKED UP HE REALIZED THAT THE CALCIUM RIDER HAD BOLUSED INTO THE PRIMARY INFUSION BAG. THE SECONDARY BAG HAD BYPASSED THE PUMP COMPLETELY. IT APPEARS THAT THE ANTI-REFLUX VALVE WITHIN THE PRIMARY TUBING HAD FAILED. THE RN HAD A 2ND RN CHECK AND THEY BOTH AGREED THAT THE IV PUMP AND TUBING HAD BEEN PROPERLY CONNECTED AND THE PUMP WAS SET-UP CORRECTLY. NO APPARENT HARM. PATIENT MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351183 LIFESHIELD PRIMARY SYMBIQ SET PIGGYBACK WITH BACK CHECK VALV TUBING, FLUID DELIVERY FPK HOSPIRA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * HOSPIRA IV PUMP| NO OTHER THERAPIES