BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6571042 · Received May 16, 2017

    Report

    Report Number
    1314492-2017-00918
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 16, 2017
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 AND DID NOT REVEAL ANY EVIDENCE OF NONCONFORMING PRODUCT. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYSTEM ERROR 324 ALARMS WHICH WERE REPRODUCED UPON POWERING UP THE DEVICE. SYSTEM ERROR 324 ALARMS WERE VERIFIED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND FOUND TO BE CAUSED BY A FAILED UPPER AUXILIARY ASSEMBLY. THE UPPER AUXILIARY ASSEMBLY 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 EXPERIENCED A SYSTEM ERROR 324 (COLOR SENSOR ERROR: FRQ) ALARM. THERE WAS NO KNOWN PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352376 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1