BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18036777 · Received October 31, 2023

    Report

    Report Number
    2016493-2023-241718
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    September 22, 2023
    Report Date
    November 27, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    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. 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 : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-241718 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-241713, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT BEING TREATED FOR DIVERTICULITIS MAY HAVE RECEIVED MORE THAN INTENDED HYDROMORPHONE DELIVERED PATIENT CONTROLLED ANALGESIA DOSES ON A LOCKOUT OF 1 MINUTE. THE INTENDED DOSING WAS 0.3 MG PER DOSE WITH A LOCKOUT INTERVAL OF 6 MINUTES. VOLUME TO BE INFUSED (VTBI) WAS HYDROMORPHONE SYRINGE 12 MG/30 ML (0.4 MG/ML); DOSE: 0.3 MG/0.75 ML CUSTOMER FOUND THIS DURING MONTHLY REVIEW. THERE WAS PATIENT INVOLVEMENT AND PER CUSTOMER "PATIENT EXPERIENCED SOME DEGREE OF DROWSINESS AND SOME MINOR INTERVENTION WAS RENDERED, SITTING UP.... PATIENT WAS DIAPHORETIC AND TACHYPNEIC. UNKNOWN IF AS A RESULT OF THIS OR BECAUSE HE WAS IN PAIN" THE PATIENT WAS MONITORED THROUGH INCENTIVE SPIROMETRY, CONTINUED ETCO2 AND THE HEAD OF THE BED WAS ELEVATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT BEING TREATED FOR DIVERTICULITIS MAY HAVE RECEIVED MORE THAN INTENDED HYDROMORPHONE DELIVERED PATIENT CONTROLLED ANALGESIA DOSES ON A LOCKOUT OF 1 MINUTE. THE INTENDED DOSING WAS 0.3 MG PER DOSE WITH A LOCKOUT INTERVAL OF 6 MINUTES. VOLUME TO BE INFUSED (VTBI) WAS HYDROMORPHONE SYRINGE 12 MG/30 ML (0.4 MG/ML); DOSE: 0.3 MG/0.75 ML CUSTOMER FOUND THIS DURING MONTHLY REVIEW. THERE WAS PATIENT INVOLVEMENT AND PER CUSTOMER "PATIENT EXPERIENCED SOME DEGREE OF DROWSINESS AND SOME MINOR INTERVENTION WAS RENDERED, SITTING UP. PATIENT WAS DIAPHORETIC AND TACHYPNEIC. UNKNOWN IF AS A RESULT OF THIS OR BECAUSE HE WAS IN PAIN" THE PATIENT WAS MONITORED THROUGH INCENTIVE SPIROMETRY, CONTINUED ETCO2 AND THE HEAD OF THE BED WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227440 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male