BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 8903710 · Received August 16, 2019

    Report

    Report Number
    1314492-2019-02838
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION OF CONCOMITANT MEDICAL PRODUCTS: BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION OF ¿FALSE UPSTREAM OCCLUSION ALARM¿ WAS NOT VERIFIED OR REPRODUCED DURING EVALUATION. INSTEAD EVALUATION DETERMINED THE ISSUE TO BE FALSE DOWNSTREAM OCCLUSION ALARMS WHICH WERE EVIDENCED THROUGH A REVIEW OF THE EVENT HISTORY LOG (EHL). THE DEVICE WAS FOUND OUT OF SPECIFICATION RELATED TO FALSE DOWNSTREAM OCCLUSION ALARMS AND THE CAUSE WAS DETERMINED TO BE THE DOWNSTREAM TUBING GUIDE WHICH WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    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 REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED FALSE UPSTREAM OCCLUSION WHICH WAS NOT REPRODUCED DURING EVALUATION. FALSE UPSTREAM OCCLUSION ALARMS WERE VERIFIED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND FOUND TO BE CAUSED BY A FAILED DOWNSTREAM TUBING GUIDE WHICH 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 FALSE UPSTREAM OCCLUSION ALARM DURING THERAPY (MEDICATION, DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). 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
    694644 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1