BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222059 · Received July 1, 2013

    Report

    Report Number
    1314492-2013-00949
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. DURING BAXTER'S EVALUATION OF THE DEVICE, FLOW RATE INACCURACY OF >10% WAS OBSERVED. EVALUATION FOUND THE UPPER VALVE, LOWER VALVE, AND UPPER FINGER TRAVEL OUT OF SPECIFICATION. THE UPPER VALVE, LOWER VALVE, AND UPPER FINGER WERE ADJUSTED TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE DELIVERED - 6% ACCURACY DURING A FLOW RATE PREVENTATIVE MAINTENANCE TEST. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. DURING BAXTER'S EVALUATION OF THE DEVICE, >10% FLOW RATE ACCURACY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297539 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1