BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 8334113 · Received February 12, 2019

    Report

    Report Number
    1314492-2019-00363
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    February 26, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED COLUMN IS ¿SETUP,¿ ¿1/ABC,¿ ¿4/JKL,¿ ¿7/STU,¿ AND THE ROUND KEY ABOVE THE ¿1/ABC¿ KEY. THE REPORTED SYMPTOM WAS VERIFIED AND FOUND TO BE CAUSED BY AN INOPERABLE KEYPAD WHICH WAS REPRODUCED DURING EVALUATION. THE CAUSE WAS DETERMINED TO BE A FAILING KEYPAD. THE KEYPAD WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. 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 KEYS EXPERIENCED A COLUMN OF KEYS NOT RESPONDING. THE COLUMN IS ¿SETUP,¿ ¿1/ABC,¿ ¿4/JKL,¿ ¿7/STU,¿ AND THE ROUND KEY ABOVE THE ¿1/ABC¿ KEY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123424 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1