BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 12168221 · Received July 14, 2021

    Report

    Report Number
    1314492-2021-02590
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K173084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 MEDICAL DEVICE PROBLEM CODE CORRECTED TO A090103 RATHER THAN A160102 INDICATED ON INITIAL MDR. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THE SPEAKER WAS LOOSE. 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 DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE CUSTOMER REPORTED LOW TO NO VOLUME FROM THE SPEAKER, WHICH WAS REPRODUCED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DETERMINED TO BE THE LOOSE SPEAKER. THE REAR CASE WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN FOLLOW-UP MDR #1 IS BEING CORRECTED FROM BLANK TO 07/21/2021.

    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 IQ PUMP HAD LOW TO NO VOLUME ON SPEAKER 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
    1065447 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1