BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 18498782 · Received January 11, 2024

    Report

    Report Number
    1314492-2024-00062
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 21, 2023
    Report Date
    April 16, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION, ' HAD AN ISSUE: KEYPAD NEEDS REPLACEMENT' WAS CONFIRMED. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE THE KEYPAD THAT HAD A LARGE PUNCTURED HOLE IN THE CENTER. THE KEYPAD REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 INVESTIGATION FINDINGS - UPDATED TO C070602 AND NOT C0402 AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP "KEYPAD NEEDS REPLACEMENT". THIS OCCURRED DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846071 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA N/A 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown