BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6447330 · Received March 30, 2017

    Report

    Report Number
    1314492-2017-00592
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    February 19, 2017
    Report Date
    May 2, 2017
    Manufacturer
    BAXTER MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. THE 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 DEVICE WAS FOUND IN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM OF 'THE PUMP SHUT OFF WHILE CONNECTED TO A PATIENT', WHICH WAS NEITHER REPRODUCED NOR CONFIRMED DURING SAMPLE EVALUATION. NO COMPONENT COULD BE IDENTIFIED FOR CAUSALITY AND THE DEVICE PASSED ALL FUNCTIONAL TESTING THEREFORE NO CORRECTION IS REQUIRED. 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. BAXTER RECEIVED AND EVALUATED THE DEVICE. THE 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 DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYSTEM ERROR 324 ALARMS WHICH WERE NOT REPRODUCED. SYSTEM ERROR 324 ALARMS WERE CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND WERE FOUND TO BE CAUSED BY DRIED FLUID RESIDE BLOCKING THE LIGHT EMITTING DIODE LIGHTS OF THE COLOR SENSOR. THE KEYHOLE ASSEMBLY WAS REPLACED TO CORRECT THIS CONDITION. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 AND TURNED OFF WITHOUT USER INPUT DURING THERAPY (MEDICATION, DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THERE WAS NO 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
    228014 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1