BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM WITH MDL

    MDR report key: 19836248 · Received July 26, 2024

    Report

    Report Number
    1314492-2024-02408
    Event Type
    Death
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 15, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    UDI-DI
    00085412091570
    PMA / PMN Number
    K133801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - IMPACT CODES UPDATED FROM F26 TO F02. ADDITIONAL INFORMATION B1, B2, B3, B5, D9, D10, F10 (CODING), H1, H3, H6 AND H11. B5: ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS STARTED ON MORPHINE IN THE ¿PCU/STEP DOWN¿ CARE AREA. THE VOLUME TO BE INFUSED WAS 48 ML AT A RATE OF 1 ML/HOUR STARTING AT 10:19AM PER THE PUMP LOG (REPORTED AS 10:16AM). AT 11:47AM THE NURSE WENT INTO THE PATIENT ROOM TO WASTE THE MORPHINE AND NOTED THE PATIENT HAD DIED. THE MORPHINE BAG WAS EMPTY. THE ¿MEDICATION HAD NOT BEEN TITRATED¿. IT WAS NOT REPORTED WHAT WAS THE CAUSE OF DEATH NOR WAS IT REPORTED IF AN AUTOPSY HAD BEEN REQUESTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING AND A REVIEW OF THE EVENT HISTORY LOG WERE PERFORMED. DEVICE EVALUATION DID NOT IDENTIFY ANY ISSUES RELATED TO THE CUSTOMER REPORTED CONDITION HOWEVER, AN INTERNAL VISUAL INSPECTION REVEALED EXCESS GREASE ON COMPONENTS OF THE MECHANISM THAT APPEARS TO HAVE BEEN APPLIED OVER BAXTER-APPLIED GREASE AND PHYSICAL DAMAGE WAS OBSERVED ON MULTIPLE COMPONENTS. THE EVENT HISTORY LOG REVEALED THE LAST PROGRAMMED INFUSION HAD A NEW INFUSION OF MORPHINE PROGRAMMED. THE INITIAL VOLUME TO BE INFUSED WAS 48 ML AT THE RATE OF 1 ML/HR. FIFTY-ONE MINUTES LATER, AN "UPSTREAM OCCLUSION!" ALARM OCCURRED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. THE PHYSICAL DAMAGE OBSERVED DURING VISUAL INSPECTION FOUND COMPROMISED PREMIUM COMPONENTS INCLUDING A CRACKED REAR CASE, DAMAGED COLOR SENSOR BRACKET, DAMAGED COMPONENTS ON THE PROCESSOR AND INPUT/OUTPUT BOARDS AND TORN TAPE ON THE ULTRASONIC SENSOR. THESE OBSERVATIONS COULD INDICATE IMPACT DAMAGE TO THE DEVICE, WHICH CAN CONTRIBUTE TO FLOW INACCURACY AS SEVERE DAMAGE CAN COMPROMISE THE PUMPING MECHANISM TO THE POINT WHERE CALIBRATED DELIVERY WAS NO LONGER ACHIEVED. A CAUTION IN THE SPECTRUM OPERATOR'S MANUAL STATES: "CAUTION: PERFORM PREVENTATIVE MAINTENANCE ANNUALLY. PUMPS SHOULD BE TESTED FOR PROPER PERFORMANCE ANNUALLY AND ALSO WHENEVER DAMAGE FROM DROPS, FLUID INTRUSION AND OTHER CAUSES IS SUSPECTED." AND A WARNING ON PAGE 22 STATES: "WARNING: PREVENT INACCURACY. THE FOLLOWING CAN CAUSE FLOW RATE INACCURACIES AND MUST BE AVOIDED: USING A DROPPED, DAMAGED, DIRTY OR WET PUMP." IT WAS DETERMINED THAT THE PHYSICAL DAMAGE TO THE DEVICE IS BEYOND REASONABLE REPAIR AND DEEMED UNSERVICEABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP FAILED ACCURACY TEST. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562222 SPECTRUM WITH MDL PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700BAX NA 00085412091570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death MORPHINE.| NI.