BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6344016 · Received February 20, 2017

    Report

    Report Number
    1314492-2017-00270
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    November 1, 2016
    Report Date
    February 20, 2017
    Manufacturer
    BAXTER MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 ALARM WHICH WAS NOT REPRODUCED. SYSTEM ERROR 345 WAS VERIFIED THROUGH A REVIEW OF THE EVENT HISTORY LOG. PER THE OPERATORS MANUAL, A SINGLE OCCURRENCE OF A SYSTEM ERROR CAN BE CLEARED IF THE DEVICE PASSED PREVENTATIVE MAINTENANCE TESTING AND THE ERROR DOES NOT RECUR. THE DEVICE WAS FOUND TO OPERATE AS DESIGNED. A NONCONFORMANCE WAS NOT INITIATED BECAUSE REVIEW OF THE EVALUATION ELEMENTS DID NOT IDENTIFY NONCONFORMING PRODUCT. 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
    126033 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1