BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 5394491 · Received January 27, 2016

    Report

    Report Number
    2016493-2016-00141
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    January 2, 2016
    Report Date
    January 7, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF NO FLUID FLOW AND THE PUMP NOT ALARMING WAS NOT CONFIRMED. A COMPREHENSIVE ANALYSIS OF THE PUMP MODULE EVENT LOG WAS PERFORMED. IT WAS NOTED THAT THERE WAS A DEVIATION FROM THE ORIGINAL INFUSION RATE AND VTBI ON THE DATE OF THE REPORTED EVENT. THE PCU EVENT LOG NOTED THE DEVICE WAS IN PUMP PRESSURE MODE AT THE TIME OF THE REPORTED INCIDENT. ON (B)(6) 2015 AT 8:57 PM, THE SOURCE PUMP MODULE WAS ATTACHED TO THE PCU; ON (B)(6) 2016 AT 12:46 PM THE MODULE WAS PROGRAMMED TO INFUSE AT 0.39ML/HR WITH A VTBI OF 30.133ML. AT 12:59 PM, THE RATE WAS CHANGED TO 0.65ML/HR WITH A VTBI OF 30.051ML. AT 1:00 PM, THE RATE WAS CHANGED TO 1.04ML/HR WITH A VTBI OF 30.045ML. AT 1:31 PM, THE RATE WAS CHANGED TO 1.3ML/HR WITH A VTBI OF 29.505ML. THE DEVICE WAS PAUSED AT 2:40 PM; THIRTY SECONDS LATER, THE MODULE WAS PROGRAMMED TO INFUSE AT 999ML/HR WITH A VTBI OF 27.986ML. AT 2:43 PM THE RATE WAS CHANGED TO 1ML/HR, HOWEVER WITH A VTBI OF 0ML THE PUMP WENT INTO KVO ONE SECOND LATER. THE ROOT CAUSE OF NO FLUID FLOW AND THE PUMP NOT ALARMING COULD NOT BE DETERMINED THROUGH REVIEW OF THE LOG ALONE, AND NO DEVICES OR DISPOSABLE SET WERE RETURNED BY THE CUSTOMER FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. DEVICES NOT RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PUMP PROGRAMMED FOR EPINEPHRINE WAS DISCOVERED TO HAVE CRIMPED TUBING IN THE PUMP, NO FLUID FLOW, AND THE PUMP DID NOT ALARM. THE EVENT WAS DISCOVERED WHEN THE PATIENT'S BLOOD PRESSURE DROPPED. NO LASTING PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51935 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other