BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4320140 · Received April 11, 2014

    Report

    Report Number
    1314492-2014-21982
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 #8 AND #9 KEYS TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #9 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #3 KEY IS PRESSED 39 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE GHI KEY IS SELECTED, GY WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED A SPECTRUM PUMP HAD A "DOUBLE TAPPING" KEYPAD. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225204 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1