BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3032174 · Received March 7, 2013

    Report

    Report Number
    1314492-2013-00211
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    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. THE DEVICE EVALUATION CONFIRMED THE #0, #1, #2, #3, #4, #5, #6, #7, #8, #9 AND (.) KEY TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE ON/OFF KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE SETUP KEY IS PRESSED SETUP FOLLOWED BY THE ON/OFF KEY WILL BE ENTERED INTERFERING WITH THE MDL DRUG SEARCH). THE FAILED KEYPAD WAS REPLACED. BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ON/OFF KEY ON A PUMP KEYPAD IS INOPERABLE. THE CUSTOMER ALSO STATED THAT THE PUMP WOULD POWER ON WITHOUT USER INPUT. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98636 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1