BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WITH MDL

    MDR report key: 20925772 · Received December 13, 2024

    Report

    Report Number
    1314492-2024-03874
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412091570
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS:ENTREGAR EN ALMACEN CARR. #2 KM 173.4. E1: INITIAL REPORTER PHONE NO.: (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, IMPROPER SHUT DOWN WAS REPRODUCED. A REVIEW OF THE HISTORY LOG REVEALED IMPROPER SHUTDOWN WAS FOUND THROUGHOUT THE LOG. THE HISTORY LOG CANNOT BE USED TO DETERMINE HOW POWER BECAME DISCONNECTED. A SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS IDENTIFIED TO BE REAR CASE DEPRESSED BATTERY CONTACT PINS DUE TO DRIED LIQUID SUBSTANCE. REAR CASE REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP POWERED OFF WITHOUT USER INPUT. THIS OCCURRED UPON DEVICE POWER UP IN THE INTENSIVE CARE UNIT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805034 SPECTRUM WITH MDL PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 35700BAX NA 00085412091570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown