BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 10627631 · Received October 5, 2020

    Report

    Report Number
    1314492-2020-03289
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE REPORTED CONDITION WAS/WAS NOT VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE CUSTOMER REPORTED SYSTEM ERROR 345 WHICH WAS NOT REPRODUCED. A REVIEW OF THE EVENT HISTORY LOG IDENTIFIED SYSTEM ERROR 345. EVALUATION DETERMINED THE CAUSALITY TO BE PROCESSOR BOARD REVISION = F (LESS THAN J) AND INPUT OUTPUT (I\O)BOARD REVISION = G (LESS THAN L). THE PROCESSOR AND I/O BOARD WERE BOTH 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 SYSTEM ERROR 345 (THERMISTOR DISPARITY). THE PROBLEM WAS FOUND DURING TESTING AT THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093036 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1