BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14681713 · Received June 13, 2022

    Report

    Report Number
    1314492-2022-02443
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION B5: IT WAS REPORTED THAT A SPECTRUM IQ PUMP KEPT ALARMING OCCLUSION. CORRECTION G4 PMA/510K # OR BLA #: K220417. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE DEVICE DID NOT REPRODUCED THE REPORTED EVENT. THE DEVICE WAS FOUND PASSING UPSTREAM AND DOWNSTREAM OCCLUSION TESTING. A REVIEW OF THE EVENT HISTORY LOG REVEALED 'KEEPS ALARMING ¿OCCLUSION¿ NO OCCLUSION' AS DOWNSTREAM OCCLUSION ALARMS. 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 AN OUT OF SPECIFICATION FORCE SENSOR. THE FORCE SENSOR 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 IQ PUMP ALARMED AIR IN LINE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989773 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown