BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 16794862 · Received April 24, 2023

    Report

    Report Number
    1314492-2023-01419
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 29, 2023
    Report Date
    June 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION H6:MEDICAL DEVICE PROBLEM CODE A070801 IS REPLACED BY A070908. THE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND DID NOT IDENTIFY ANY ISSUES RELATED TO THE CUSTOMER REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 DID NOT HAVE THE SET LOADING INSTRUCTIONS POP UP WHEN SLIDE CLAMP WAS INSERTED INTO KEYHOLE. THIS OCCURRED DURING TESTING AT THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601492 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown