BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 8861342 · Received August 5, 2019

    Report

    Report Number
    1314492-2019-02607
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED DEVICE WOULD NOT RECOGNIZE BUBBLE WHICH WAS NOT REPRODUCED DURING EVALUATION. THE UPSTREAM/ULTRASONIC SENSOR WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WOULD NOT RECOGNIZE BUBBLE. THE PROBLEM WAS FOUND IN THE BIOMED SERVICE DEPARTMENT DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654997 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1