BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 7550298 · Received May 29, 2018

    Report

    Report Number
    1314492-2018-01814
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Report Date
    May 29, 2018
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS VERIFIED. THE REPORTED ISSUE COULD BE REPRODUCED DURING THE DEVICE EVALUATION. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM "#4 KEY NOT WORKING".DURING DEVICE EVALUATION, WHEN THE #1(ABC), #2(DEF), AND #3(GHI) KEYS WERE PRESSED, THE OUTPUT OF THE KEYS WERE THE LETTERS H AND L AND THE REMAINING KEYS WERE INOPERABLE. THE KEYPAD WAS REPLACED TO FIXED THE PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP EXPERIENCED THAT THE #4 KEY IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390382 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1