BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 6821605 · Received August 25, 2017

    Report

    Report Number
    2016493-2017-00540
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 15, 2017
    Report Date
    August 3, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8100, THERAPY DATE (B)(6) 2017. THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF COMMUNICATION AND CHANNEL ERROR MESSAGES WAS CONFIRMED. PHYSICAL INSPECTION SHOWED CONTAMINATION ON PINS OF THE LEFT IUI CONNECTORS OF THE PCU AND SYRINGE MODULE SN (B)(4) (CHANNEL B). ANALYSIS OF THE PCU EVENT LOG SHOWS THAT THREE SYRINGE PUMP MODULES WERE ACTIVELY INFUSING. AT 4:40AM ON (B)(6) 2017, CHANNEL A (INFUSING VECURONIUM) AND CHANNEL B (INFUSING MORPHINE) WERE RECORDED TO HAVE BEEN REMOVED RESULTING IN A CHANNEL DISCONNECT ALARM. CHANNEL A THEN EXPERIENCED A CHANNEL SOFT FAULT ERROR 13-1033-149 AND STOPPED ITS INFUSION. CHANNEL B THEN ALARMED FOR COMMUNICATION ERROR WITH ITS INFUSION CONTINUING TO RUN WHILE IN AN ALARM STATE AS DESIGNED. A FEW SECONDS LATER A PUMP MODULE (CHANNEL D) WAS RECORDED AS BEING ATTACHED, REMOVED AND ATTACHED. AT 4:42AM THE USER SELECTED THE CHANNEL OFF KEY ON CHANNEL B STOPPING ITS INFUSION. CHANNEL C (INFUSING MIDAZOLAM) WAS UNAFFECTED BY THE CHANNEL DISCONNECT AND COMMUNICATION ERROR. AT 4:43 AM THE USER TURNED OFF THE INFUSION ON CHANNEL C WHICH SHUT OFF THE SYSTEM. AGGRESSIVE PHYSICAL MANIPULATION DURING A PROLONGED TEST INFUSION WAS UNABLE TO REPLICATE THE EVENT. THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT IDENTIFIED BUT THE LEFT IUI CONNECTORS ON BOTH THE PCU AND CHANNEL B HAD CONTAMINATION WITHIN THE CONTACT AREAS OF SOME PINS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT VECURONIUM WAS INFUSING ON CHANNEL A, MORPHINE ON CHANNEL B, AND VERSED WITH NOREPINEPHRINE ON CHANNEL C. WHEN THE USER ATTEMPTED TO ATTACH AND START AN ADDITIONAL FOURTH MODULE, A COMMUNICATION ERROR OCCURRED ON CHANNEL A AND A CHANNEL ERROR OCCURRED ON CHANNEL B. THE PC UNIT WAS THEN TURNED OFF AND REPROGRAMMED. THE PATIENT EXPERIENCED TEMPORARY VARIABLE BLOOD PRESSURES AND OXYGEN DESATURATION AND THE VITAL SIGNS STABILIZED AFTER THE INFUSIONS RESUMED. NO OTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600635 ALARIS SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (2)8110,8015,(3)SYR TUBE,PRI TUBING, TD (B)(6)