BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 16812691 · Received April 26, 2023

    Report

    Report Number
    2016493-2023-153686
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 30, 2023
    Report Date
    May 5, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-153686 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-153685, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Additional Manufacturer Narrative · 0

    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. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ON EPIDURAL/PCA OF BUPIVACAINE-HYDROMORPHONE 0.5MG. THE ORDER FOR INFUSION WAS 6ML CONTINUOUS INFUSION ALONG WITH A DOSE REQUEST 2ML BOLUS DOSE WITH A 20-MINUTE LOCK OUT. THE PATIENT HAD EXPERIENCED OVER SEDATION AND AS A RESULT REQUIRED NARCAN. ON THE CUSTOMERS INTERNAL REVIEW OF THE INFUSION REPORT, CUSTOMER STATED "IT LOOKS LIKE THEY ONLY SET UP THE 6 ML/HR. CONTINUOUS." THE CUSTOMER REPORTED THAT THERE WAS NO DEVICE MALFUNCTION. THE CUSTOMER IS REQUESTING THE MANUFACTURER TO PERFORM A KEYSTROKE LOG REVIEW TO ASSESS IF ANY 2ML BOLUS DOSES WERE PROGRAMMED AND GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ON EPIDURAL/PCA OF BUPIVACAINE-HYDROMORPHONE 0.5MG. THE ORDER FOR INFUSION WAS 6ML CONTINUOUS INFUSION ALONG WITH A DOSE REQUEST 2ML BOLUS DOSE WITH A 20-MINUTE LOCK OUT. THE PATIENT HAD EXPERIENCED OVER SEDATION AND AS A RESULT REQUIRED NARCAN. ON THE CUSTOMERS INTERNAL REVIEW OF THE INFUSION REPORT, CUSTOMER STATED "IT LOOKS LIKE THEY ONLY SET UP THE 6 ML/HR. CONTINUOUS." THE CUSTOMER REPORTED THAT THERE WAS NO DEVICE MALFUNCTION. THE CUSTOMER IS REQUESTING THE MANUFACTURER TO PERFORM A KEYSTROKE LOG REVIEW TO ASSESS IF ANY 2ML BOLUS DOSES WERE PROGRAMMED AND GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866600 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention