BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4943389 · Received July 27, 2015

    Report

    Report Number
    1314492-2015-07975
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 6, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT NO.: 252272. BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM OF AN INOPERABLE (OK) KEY, WHICH WAS REPRODUCED. THE DEVICE EVALUATION CONFIRMED THE (OK) TO BE INOPERABLE AND ALSO FOUND ALL NUMERICAL KEYS AND THE (.) KEY TO BE INOPERABLE. ADDITIONALLY, AN AUTOMATIC OUTPUT OF THE (OK) KEY OCCURED FOLLOWING THE USE OF ANY KEY. EVALUATION FOUND THE CAUSE TO BE A LOOSE CONNECTION BETWEEN THE KEYPAD FLEX AND THE J5 CONNECTOR OF THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). THE CONNECTION BETWEEN THE KEYPAD FLEX AND THE J5 CONNECTOR OF THE I/O PCB WAS ADJUSTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP'S OK DOES NOT WORK. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485952 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1