BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3182508 · Received June 11, 2013

    Report

    Report Number
    1314492-2013-00751
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE DEVICE WAS PERFORMANCE TESTED FOR (B)(4) HOURS WITH NO KEYPAD OUTPUT RESPONSE ANOMALIES APPARENT DURING EVALUATION. THE KEYPAD WAS DELAMINATED AND EXAMINED UNDER A MICROSCOPE AND NO FAILURES WERE EVIDENT ON THE KEYPAD. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "OK" KEY ON A PUMP KEYPAD ACTS LIKE THE SCROLL DOWN SOFT KEY DIRECTLY ABOVE IT. THE CUSTOMER STATED THAT AN INFUSION COULD NOT BE PROGRAMMED BECAUSE A CARE AREA SELECTION COULD NOT BE MADE, AS THE MENU WOULD CONTINUE TO SCROLL DOWN WHEN THE "OK" KEY WAS PRESSED. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264813 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1