BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 13477701 · Received February 8, 2022

    Report

    Report Number
    2016493-2022-104347
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    December 1, 2021
    Report Date
    February 10, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED OF THIS MDR REPORT. 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. NOT APPLICABLE. DEVICE EVALUATED BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN AN OPERATING ROOM AN INFUSION OF PHENYLEPHRINE (10MG /250ML) WAS PAUSED BY ANESTHESIA FOR AN EXTENDED PERIOD AND WAS LATER FOUND FLOWING MEDICATION. THE PATIENT WAS IN A STATE OF HYPERTENSION WITH BLOOD PRESSURE MEASURED VIA ARTERIAL LINE AT 181/111. "SEVERAL" DOSES OF PROPOFOL GIVEN FOLLOWED BY A CONTINUOUS PROPOFOL INFUSION. THE LINE FOR PHENYLEPHRINE WAS DISCONNECTED AND MEDICATION WAS NOTED TO BE FLOWING FROM END OF THE TUBING WHILE THE PUMP WAS ON STANDBY. THE PHENYLEPHRINE LINE WAS REMOVED. THE CUSTOMER INDICATED THE EVENT OCCURRED BETWEEN APPROXIMATELY 1411 - 1527. THERE WAS A PATIENT INVOLVEMENT BUT NO HARM FOLLOWING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN AN OPERATING ROOM AN INFUSION OF PHENYLEPHRINE (10MG /250ML) WAS PAUSED BY ANESTHESIA FOR AN EXTENDED PERIOD AND WAS LATER FOUND FLOWING MEDICATION. THE PATIENT WAS IN A STATE OF HYPERTENSION WITH BLOOD PRESSURE MEASURED VIA ARTERIAL LINE AT 181/111. "SEVERAL" DOSES OF PROPOFOL GIVEN FOLLOWED BY A CONTINUOUS PROPOFOL INFUSION. THE LINE FOR PHENYLEPHRINE WAS DISCONNECTED AND MEDICATION WAS NOTED TO BE FLOWING FROM END OF THE TUBING WHILE THE PUMP WAS ON STANDBY. THE PHENYLEPHRINE LINE WAS REMOVED. THE CUSTOMER INDICATED THE EVENT OCCURRED BETWEEN APPROXIMATELY 1411 - 1527. THERE WAS A PATIENT INVOLVEMENT BUT NO HARM FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896784 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention 8015