BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 8663340 · Received June 3, 2019

    Report

    Report Number
    1314492-2019-01890
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    January 16, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED FALSE DOWNSTREAM OCCLUSION, WHICH WAS NOT REPRODUCED DURING EVALUATION. A REVIEW OF THE EVENT HISTORY LOG IDENTIFIED DOWNSTREAM OCCLUSION. THE CAUSE WAS DETERMINED TO BE THE DOWNSTREAM TUBING GUIDE DEPTH OUT OF RANGE. THE DOWNSTREAM TUBING GUIDE 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 FALSE DOWNSTREAM OCCLUSION. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458042 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1