BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 16308250 · Received February 6, 2023

    Report

    Report Number
    1314492-2023-00259
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    December 9, 2022
    Report Date
    March 13, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE REPORTED ISSUE MAY POTENTIALLY RELATED TO FA-2021-056. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INFUSION OF PHENYLEPHRINE (VASOCONSTRICTOR/ VASOPRESSOR) USING THE SPECTRUM INFUSION PUMP, THE PATIENT BECAME HYPOTENSIVE. IT WAS STATED THE ANESTHESIA TEAM WAS CALLED. AND THE PUMP WAS NOTED TO ALARM ¿AT A LOW VOLUME¿, AND THE "VOLUME TO BE INFUSED WAS REPROGRAMMED". THE REPORTER FURTHER ADDED THAT "AGAIN, THE PUMP ALARMED AT LOW VOLUME AFTER ABOUT 15 MINUTES". THE VOLUME WAS READJUSTED ONCE AGAIN WHEN SHORTLY AFTER AN AIR IN LINE OCCURRED. AT THIS TIME, TUBING NOTED TO BE KINKED AND FULL OF AIR. THE BAG HAD NOT DECREASED IN VOLUME AT ALL. AFTER THE TUBING AND PUMP WERE CHANGED, THE PATIENT BECAME ACUTELY HYPERTENSIVE. PHENYLEPHRINE WAS RAPIDLY TITRATED DOWN AND THE HYPOTENSION STATED SHORTLY AFTER THE NURSE HUNG A NEW BAG OF PHENYLEPHRINE. THE PATIENT'S BLOOD PRESSURE WAS STABILIZED TO 136/81. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64447 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PHENYLEPHRINE