BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896572 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03541
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 20, 2013
    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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM, WHICH WAS REPRODUCED. IMPROPER KEYPAD FUNCTION WAS CONFIRMED AND WAS DETERMINED TO BE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT THE #5-#9 KEYS ARE INOPERABLE, AND WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #6 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #6 KEY IS PRESSED 16 WILL BE DISPLAYED. WHEN AN ALPHABETIC MODE AND THE ABC KEY IS SELECTED, AP WILL BE DISPLAYED INTERFACING WITH THE MDL DRUG SEARCH). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER THE REPORT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP'S KEYPAD WAS NOT FUNCTIONING PROPERLY. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43214 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1