BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLING SV

    MDR report key: 16311084 · Received February 7, 2023

    Report

    Report Number
    16311084
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 24, 2023
    Report Date
    January 30, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    DXN
    UDI-DI
    7290013030030
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS AN ONGOING INVESTIGATION BETWEEN (B)(6) HOSPITAL BIOMEDICAL ENGINEERING IN ASSOCIATION WITH BAXTER CLINICAL REPRESENTATIVES FOLLOWING A SIMILAR EVENT ON REDACTED DATE. A PATIENT ON BLISS 11 ICU WAS CONNECTED TO A GE B850 V3 PATIENT MONITOR WITH NORMAL BRADY SINUS RHYTHM AS DETERMINED BY THE BEDSIDE MONITOR. PATIENT WAS THEN CONNECTED TO THE BAXTER STARLING SV NICOM TO DETERMINE PATIENT¿S FLUID RESPONSE TO IV FLUID BOLUS. ONCE THE NICOM LEADS WERE ATTACHED TO THE PATIENT AND CONNECTED TO THE DEVICE VIA THE PATIENT CABLE, THE PATIENT¿S WAVEFORM DISPLAYED AS A DIMINISHED/DISRUPTED QRS COMPLEX FOLLOWED BY ASYSTOLE ON THE BEDSIDE MONITOR. THE GE BEDSIDE MONITOR ALARMED AS ASYSTOLE ALERTING STAFF OF THE CRITICAL EVENT. STAFF IMMEDIATELY EXAMINED THE PATIENT AND CONFIRMED A FALSE READING OF ASYSTOLE FROM THE MONITOR. WHEN THE NICOM LEAD CABLES WERE DISCONNECTED FROM THE PATIENT CABLE, NORMAL SINUS RHYTHM RETURNED AS SHOWN ON THE BEDSIDE MONITOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. MANUFACTURER RESPONSE FOR NON-INVASIVE CARDIAC MONITOR, CHEETAH MEDICAL (PER SITE REPORTER). MANUFACTURER RESPONDED IMMEDIATELY AND WERE ON SITE TO HELP TROUBLESHOOT THE INCIDENT. THIS REMAINS AN ONGOING PROCESS TO DETERMINE THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227138 STARLING SV SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN BAXTER HEALTHCARE CORPORATION 7290013030030

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Female