BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6825830 · Received August 28, 2017

    Report

    Report Number
    1314492-2017-01626
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Report Date
    August 28, 2017
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 SERVICE HISTORY RECORD (SHR) 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 UNABLE TO BE REPRODUCED WHILE RUNNING A LOADED SET. SYSTEM ERROR 324 ALARMS WERE VERIFIED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND FOUND TO BE CAUSED BY AN OUT OF CALIBRATION COLOR SENSOR. THE COLOR SENSOR WAS CALIBRATED 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
    603963 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1