BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 18830917 · Received March 4, 2024

    Report

    Report Number
    1314492-2024-00595
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 4, 2024
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE REPORTER WAS UNABLE TO BE REACHED TO CLARIFY IF THE DEVICE WOULD BE RETURNED FOR INVESTIGATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A SERVICE HISTORY REVIEW REVEALED THE DEVICE WAS LAST SERVICED 2/19/2016. THERE IS NO INDICATION THAT THE PARTS REPLACED DURING PRIOR SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, NOR WOULD THIS INDICATE NONCONFORMING PRODUCT. IT IS UNKNOWN IF THERE HAS BEEN ANY 3RD PARTY REPAIR PERFORMED ON THIS DEVICE. THE LAST KNOWN FACILITY TO HAVE OWNED THIS PUMP INDICATED TO BAXTER THAT THE PUMP IS DOCUMENTED AS HAVING PREVENTIVE MAINTENANCE PERFORMED IN 2017 AND SINCE 2018 THEY HAVE NOT BEEN ABLE TO LOCATE THE PUMP AND IT IS RETIRED IN THEIR SYSTEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP OVER INFUSED DURING THERAPY. THE REPORTER DID NOT PROVIDE THE MEDICATION BEING INFUSED, RATE PARAMETERS, OR ANY CLINICAL SET UP INFORMATION. THE INVOLVED PATIENT PASSED AWAY ON AN UNREPORTED DATE. THE CAUSE OF DEATH OR IF AN AUTOPSY WAS PERFORMED WAS NOT REPORTED. REPEATED ATTEMPTS WERE MADE TO THE CONTACT NUMBER PROVIDED HOWEVER NO FURTHER DETAILS WERE ABLE TO BE OBTAINED REGARDING THE EVENT. WHEN ATTEMPTING TO LEAVE A VOICE MESSAGE A VOICE RECORDING WOULD PLAY THAT SEEMS TO ECHO THE SAUL GOODMAN CHARACTER FROM "BREAKING BAD" AND "BETTER CALL SAUL", AND THEN IMMEDIATELY DISCONNECTED WITH NO OPTION TO LEAVE A VOICE MESSAGE FOR A RETURN CALL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680125 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death