BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUP

    MDR report key: 10197590 · Received June 25, 2020

    Report

    Report Number
    1314492-2020-02042
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BAXTER HEALTHCARE - CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE CUSTOMER REPORTED 'DOWNSTREAM OCCLUSION' WHICH WAS REPRODUCED THROUGH TROUBLESHOOTING OF THE DEVICE. A REVIEW OF THE EVENT HISTORY LOG IDENTIFIED THE PRESENCE OF MULTIPLE 'DOWNSTREAM OCCLUSION!' MESSAGES. THE CAUSE WAS DETERMINED TO BE AN OUT OF SPECIFICATION FORCE SENSOR WHICH 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 ALARMED DOWNSTREAM OCCLUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660590 SPECTRUM INFUSION PUP INFUSION PUMP FRN BAXTER HEALTHCARE - CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1