BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS 3ND

    MDR report key: 21245924 · Received January 27, 2025

    Report

    Report Number
    1649914-2025-00001
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 26, 2025
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624531004
    PMA / PMN Number
    K201984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RECEIVED, DECONTAMINATED, AND THOROUGHLY INSPECTED. DURING THE INSPECTION, DRIED FLUID WAS OBSERVED ON THE ARREST PUMP MICROSWITCH AND ACTUATOR, WHILE NO DAMAGE WAS FOUND ON THE DRUG PISTON RUBBER COVER DRUM. THIS SUGGESTS THAT FLUID INTRUSION OCCURRED DUE TO THE INCORRECT INSTALLATION OF AN ARREST CARTRIDGE WITHOUT A PLUNGER, ALLOWING PRESSURIZED FLUID TO ACCUMULATE AROUND THE DRUG PISTON. THE AFFECTED COMPONENTS WERE REPLACED, AND THE DEVICE SUCCESSFULLY PASSED ALL OPERATIONAL VERIFICATION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE OPERATOR ERROR, SPECIFICALLY THE INSTALLATION OF AN ARREST CARTRIDGE WITHOUT A PLUNGER, WHICH LED TO THE REPORTED ISSUE. AT THIS TIME, NO CORRECTIVE ACTION IS BEING IMPLEMENTED, AS THE FAILURE REMAINS AN ISOLATED OCCURRENCE. HOWEVER, QUEST MEDICAL WILL CONTINUE TO MONITOR THIS ISSUE FOR ANY EMERGING TRENDS AND TAKE APPROPRIATE ACTION IF NECESSARY.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A STUDENT INITIATED THE SETUP PRIOR TO PRIMING. THE STUDENT INSTALLED THE CARTRIDGE WITHOUT THE PLUNGER, CONTRARY TO THE INSTRUCTIONS OUTLINED IN THE IFU. THIS CAUSED LEAKAGE OF FLUIDS OVER THE CONSOLE. THE PERFUSIONIST IDENTIFIED THE ISSUE AND REPLACED THE CARTRIDGE, COMPLETED THE PRIMING PROCESS, AND INITIATED THE CASE. THE ALLEGED ISSUE THEN OCCURED DURING THE PROCEDURE. QUEST IS WAITING FOR THE CONSOLE. INVESTIGATION WILL INITIATE UPON THE RECEIPT OF CONSOLE.

    Description of Event or Problem · 0

    A PERFUSIONIST AT (B)(6) IN (B)(6), ONT, REPORTED AN ISSUE WITH AN MPS3 ND CONSOLE TO A QUEST REPRESENTATIVE. IT WAS STATED THAT DURING A CASE, THE ARREST AGENT APPEARED TO DELIVER ITS CONTENTS FASTER THAN EXPECTED. WHEN A REFILL WAS ATTEMPTED; THE PLUNGER UNEXPECTEDLY PUSHED THE ENTIRE CONTENTS OUT AT ONCE. A SUBSEQUENT REFILL TEST USING SALINE YIELDED THE SAME RESULT. IT WAS DISCLOSED THAT DURING THE INITIAL SETUP, THE CARTRIDGE WAS INSTALLED WITHOUT THE PLUNGER ATTACHED, CAUSING APPROXIMATELY 10-20CC OF FLUID TO SPILL ONTO THE UNIT. THIS INCIDENT RESULTED IN AN EXTENDED ON-PUMP TIME AND REQUIRED THE PATIENT TO UNDERGO A BLOOD TRANSFUSION, AS EXCESS POTASSIUM NEEDED TO BE PURGED FROM THE MPS DISPOSABLE. THE CONSOLE HAS BEEN REMOVED FROM SERVICE AND WILL BE RETURNED TO QUEST MEDICAL FOR INVESTIGATION.

    Description of Event or Problem · 0

    A PERFUSIONIST AT (B)(6), REPORTED AN ISSUE WITH AN MPS3 ND CONSOLE TO A QUEST REPRESENTATIVE. IT WAS STATED THAT DURING A CASE, THE ARREST AGENT APPEARED TO DELIVER ITS CONTENTS FASTER THAN EXPECTED. WHEN A REFILL WAS ATTEMPTED, THE PLUNGER UNEXPECTEDLY PUSHED THE ENTIRE CONTENTS OUT AT ONCE. A SUBSEQUENT REFILL TEST USING SALINE YIELDED THE SAME RESULT. IT WAS DISCLOSED THAT DURING THE INITIAL SETUP, THE CARTRIDGE WAS INSTALLED WITHOUT THE PLUNGER ATTACHED, CAUSING APPROXIMATELY 10-20CC OF FLUID TO SPILL ONTO THE UNIT. THIS INCIDENT RESULTED IN AN EXTENDED ON-PUMP TIME AND REQUIRED THE PATIENT TO UNDERGO A BLOOD TRANSFUSION, AS EXCESS POTASSIUM NEEDED TO BE PURGED FROM THE MPS DISPOSABLE. THE CONSOLE HAS BEEN REMOVED FROM SERVICE AND WILL BE RETURNED TO QUEST MEDICAL FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759071 MPS 3ND MPS 3ND CONSOLE DTR QUEST MEDICAL, INC. 5301000ND 20634624531004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention