BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCU UNIT

    MDR report key: 5922686 · Received September 1, 2016

    Report

    Report Number
    2016493-2016-00656
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    August 10, 2016
    Report Date
    August 12, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A SYSTEM ERROR THAT DISPLAYED ERROR CODE 13-1033-149 DURING INFUSION WAS CONFIRMED. AN 800.8000 ERROR CODE WAS RECORDED IN THE DEVICE ERROR LOG FOR THE INCIDENT. THE PCU EVENT LOG SHOWED THAT AFTER CHANGING THE DOSE OF THE NOREPINEPHRINE INFUSION AND STARTING THE INFUSION, THE PUMP MODULE ALARMED FOR A CHANNEL ERROR CODE 240.4150 AND THE INFUSION STOPPED. THE CHANNEL ERROR WAS ACKNOWLEDGED AND THE START KEY PRESSED. THE PCU THEN ALARMED FOR THE SYSTEM ERROR CODE 13-1033-149. INITIAL TESTING WAS UNABLE TO REPLICATE THE SYSTEM ERROR CODE; THIS IS BELIEVED TO BE DUE TO TIMING OF EVENTS. THE ERROR EVENT WAS REPLICATED BY CREATING A CHANNEL ERROR BY ANOTHER MEANS IN WHICH THE TIMING COULD BE EASILY REPLICATED. INVESTIGATION HAS SHOWN THAT THE ERROR OCCURS WHEN A USER ATTEMPTS TO START A GUARDRAIL INFUSION ON A PUMP MODULE THAT IS CURRENTLY IN A CHANNEL ERROR STATE. THE ISSUE HAS NOT BEEN DUPLICATED FOR BASIC INFUSIONS. THE REPORT THAT THE SYSTEM ERROR EVENT SHUT DOWN ALL INFUSING CHANNELS WITHOUT NOTICE WAS NOT CONFIRMED. BY DESIGN DURING A SYSTEM ERROR EVENT THE INFUSING MODULES WILL CONTINUE TO INFUSE AT THE LAST PROGRAMMED RATE WITHOUT THE ABILITY TO MAKE ANY PROGRAMMING CHANGES. THE LOG ANALYSIS CONFIRMED THAT ALL THE INFUSING MODULES DISPLAYED A COMMUNICATION ERROR AS DESIGNED, CONTINUED TO INFUSE, AND WERE STOPPED BY USER SELECTION OF THE SYSTEM OFF KEY ON THE PCU. PHYSICAL INSPECTION NOTED THE DEVICES TO BE IN GOOD CONDITION WITH NO ANOMALIES OBSERVED. WHEN THE PUMP MODULE WAS POWERED ON IT DISPLAYED A CONSTANT 'CHECK IV' ALARM WHILE THE DOOR WAS CLOSED WITH NO SET INSTALLED. THE UPPER PRESSURE SENSOR WAS NOTED TO BE IN A CONSTANT MALFUNCTIONING STATE. THE CAUSE FOR THE MALFUNCTIONING PRESSURE SENSOR WHICH INDUCED THE CHANNEL ERROR WAS NOT DETERMINED. THE ROOT CAUSE FOR THE SYSTEM ERROR IS ATTRIBUTED TO A SOFTWARE ISSUE.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE CUSTOMER DID NOT REPORT THE EVENT DATE, THE LOG INDICATES THE LIKELY DATE AS (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR OCCURRED WITH A PCU THAT HAD 4 CHANNELS ATTACHED, WITH ALL OF THEM INFUSING. REPORTEDLY, TWO CHANNELS WITH "HIGH DOSE PRESSORS" AND TWO OTHERS WITH UNSPECIFIED SEDATION "SHUT DOWN WITHOUT NOTICE." THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 60'S/40'S (BASELINE UNKNOWN); THE NURSE WAS IN THE PATIENT'S ROOM AT THE TIME OF THE EVENT AND HE CHANGED THE INFUSIONS OVER TO A NEW SYSTEM. THE PATIENT'S BLOOD PRESSURE IMPROVED AFTER THE INFUSIONS WERE RESTARTED ON A DIFFERENT SYSTEM, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION OR LASTING HARM TO THE PATIENT. THE CUSTOMER REPORTED THAT THE DEVICE ERROR MESSAGE DISPLAYED WAS "SYSTEM ERROR: OPERATING CHANNELS WILL CONT. AS PROGRAMMED. REPLACE PROGRAMMING MODULE W/AN OPERATIONAL UNIT AS SOON AS POSSIBLE. SETTINGS UNRESTORABLE. RECORD BEFORE PRESSING SYSTEM ON TO POWER DOWN. CODE 13-1033-149."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573293 ALARIS PCU UNIT PUMP, INFUSION FRN CAREFUSION 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8015,(3)8100,(4)PRI TUBING