BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS CC GUARDRAILS PLUS SYRINGE PUMP

    MDR report key: 2973890 · Received February 15, 2013

    Report

    Report Number
    MW5029040
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2012
    Report Date
    January 31, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT IN SEPTIC SHOCK RECEIVING A NORADRENALINE (NOREPINEPHRINE) - INFUSION VIA AN ALARIS CC GUARDRAILS PLUS SYRINGE PUMP (CAREFUSION, SAN DIEGO CA, USA) RECEIVED AN INAPPROPRIATE DOSAGE OF NORADRENALINE RESULTING IN A SHARP RISE IN ARTERIAL BLOOD PRESSURE. ACCORDING TO CONVENTION AND INTERNATIONAL LITERATURE THE DOSAGE OF CATECHOLAMINES AND VASOPRESSORS ON OUR ICU ARE HANDLED IN UG/KG/MIN. UNTIL A RECENT SOFTWARE UPDATE THE DISPLAY OF THE SYRINGE PUMPS SHOWED ALL NUMBERS BEFORE AND AFTER THE DECIMAL POINT IN EQUAL FONT SIZE. NOW, THE NUMBERS AFTER THE DECIMAL POINT ARE DISPLAYED IN A DISTINCT SMALLER FONT SIZE WHICH MEANS THAT THEY ARE NOT ANYMORE LEGIBLE FROM A DISTANCE OF MORE THAN ONE METER. IN THIS CASE, AFTER A WRONG ADJUSTMENT OF THE SETTING OF THE PUMP, THE ATTENDING PHYSICIAN WAS NOT AWARE OF THE MIS-PROGRAMMING OF THE PUMP BECAUSE HE MISREAD THE VALUES ON THE SYRINGE-PUMP DISPLAY. THIS SERIOUS SAFETY PROBLEM HAS RECENTLY BEEN REPORTED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69382 ALARIS CC GUARDRAILS PLUS SYRINGE PUMP SYRINGE PUMP FRN CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening