BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3012603 · Received February 21, 2013

    Report

    Report Number
    1314492-2013-00136
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND THE DEVICE PASSED UPSTREAM AIR DETECTION TESTING. THE DEVICE DID NOT PASS UPPER AND LOWER FLUID NUMBERS TESTING AND AS A RESULT, THE ULTRASONIC SENSOR WAS REPLACED. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS CONSTANTLY ALARMING FOR AIR-IN-LINE D; DURING AN IVP INFUSION (PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER STATED THAT THE FACILITY COULD NOT REPRODUCE THE ALARM DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77378 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1