BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 12758100 · Received November 7, 2021

    Report

    Report Number
    2016493-2021-69158
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 14, 2021
    Report Date
    January 3, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT PER FAILURE INVESTIGATION REPORT, 8110 S/N (B)(4) WAS DETERMINED TO BE A CONCOMITANT. PLEASE REFER TO MFR REPORT #2016493-2022-100000 FOR THE SUSPECT DEVICE, NOT PREVIOUSLY REPORTED BY THE CUSTOMER BUT WAS DISCOVERED THROUGH FAILURE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RED ERROR MESSAGE SPONTANEOUSLY SAYING "COMMUNICATION ERROR" AND PUMP WAS NOT WORKING. WHILE NURSE WERE SOURCING ANOTHER PUMP TO MOVE THE INFUSIONS OVER, THE INFUSIONS REMAINED ON THIS PUMP. WHEN THE NURSE OBTAINED ANOTHER PUMP, BEFORE MOVING ANY INFUSIONS OVER OR ALTERING THE PUMP THE PATIENTS SBP SUDDENLY ROSE TO 240 WHO COULD HAVE SIGNIFICANT IMPACTS ON THE PATIENT. THE PATIENT WAS A CABG FORM THE PREVIOUS DAY. THE PATIENT HAD NORADRENALINE RUNNING AT 12MLS/HR BUT THE PATIENT DID NOT HAVE ANY OTHER INFUSIONS RUNNING THAT COULD HAVE CAUSED THIS JUMP IN BP. THERE WAS NO ERROR MESSAGES OR ALARMS ON THE PUMP AT THIS TIME. INFUSIONS RUNNING ON RIGHT OF PUMP WERE ACTRAPID AND PROPOFOL, THESE TWO MODULES HAD THE ERROR MESSAGE. NORADRENALINE WAS RUNNING ON THE LEFT SIDE OF THE PUMP BUT NO ERROR MESSAGE WAS SHOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RED ERROR MESSAGE SPONTANEOUSLY SAYING "COMMUNICATION ERROR" AND PUMP WAS NOT WORKING. WHILE NURSE WERE SOURCING ANOTHER PUMP TO MOVE THE INFUSIONS OVER, THE INFUSIONS REMAINED ON THIS PUMP. WHEN THE NURSE OBTAINED ANOTHER PUMP, BEFORE MOVING ANY INFUSIONS OVER OR ALTERING THE PUMP THE PATIENTS SBP SUDDENLY ROSE TO 240 WHO COULD HAVE SIGNIFICANT IMPACTS ON THE PATIENT. THE PATIENT WAS A CABG FORM THE PREVIOUS DAY. THE PATIENT HAD NORADRENALINE RUNNING AT 12MLS/HR BUT THE PATIENT DID NOT HAVE ANY OTHER INFUSIONS RUNNING THAT COULD HAVE CAUSED THIS JUMP IN BP. THERE WAS NO ERROR MESSAGES OR ALARMS ON THE PUMP AT THIS TIME. INFUSIONS RUNNING ON RIGHT OF PUMP WERE ACTRAPID AND PROPOFOL, THESE TWO MODULES HAD THE ERROR MESSAGE. NORADRENALINE WAS RUNNING ON THE LEFT SIDE OF THE PUMP BUT NO ERROR MESSAGE WAS SHOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662640 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention