BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUMP CONSOLE

    MDR report key: 8797026 · Received July 17, 2019

    Report

    Report Number
    3006073153-2019-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 24, 2019
    Manufacturer
    SPECTRUM MEDICAL LTD.
    Product Code
    DTQ
    UDI-DI
    05060434420008
    PMA / PMN Number
    K173834
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SAFETY CORRECTION WILL BE ISSUED. NO CHANGE TO THE RISK PROFILE WAS REQUIRED. STANDARD RISK CONTROL IS TO HAND CRANK PUMP IF THERE IS A PUMP STOPPAGE. THE SOFTWARE IS ON THE QUANTUM WORKSTATION AND HAS BEEN UPDATED 13TH JUNE 2019. THE UPDATE CONTAINS SOFTWARE THAT UPDATES FIRMWARE TO ANY CONNECTED ACCESSORY (DEVICE) E.G. PUMP CONSOLE POWER UNIT, ROLLER PUMPS. (B)(4).

    Description of Event or Problem · 1

    SPECTRUM MEDICAL LTD RECEIVED AN INCIDENT REPORT ON 24TH MAY 2019 THAT THE QUANTUM PUMP CONSOLE SHUT DOWN ON (B)(6) 2019 DURING TETRALOGY OF FALLOT OPEN HEART SURGERY. HAND CRANK OF THE PUMP WAS USED TO MAINTAIN PATIENT SUPPORT, OPERATION COMPLETED SUCCESSFULLY. NO INJURY TO THE PATIENT. THE PERFUSION SYSTEM IDENTIFIER FROM (B)(6) FOR THIS PARTICULAR HLM WAS IDENTIFIED VIA THE SYSTEM MONITOR, QWS (B)(4). SUMMARY OF THE ASSESSMENT: THE SOFTWARE TEAM REVIEWED THE INCIDENT REPORT AND THE DIAGNOSTIC LOGS AND HAVE IDENTIFIED THAT INCORRECT DATA WAS QUERIED FROM THE BATTERY FIRMWARE LEADING TO POWER LOSS TO THE ACCESSORY PORTS ON THE HLM. IT WAS DETERMINED THAT THE CORRECTIVE ACTION IS A SOFTWARE UPDATE THAT WILL FIX THE VULNERABILITY THAT CREATED THIS MALFUNCTION OF THE POWER SUPPLY. THIS SAME ISSUE WAS IDENTIFIED IN MDR-001 REPORT. A FIELD SAFETY CORRECTION WILL BE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592727 QUANTUM PUMP CONSOLE HEART LUNG MACHINE DTQ SPECTRUM MEDICAL LTD. 05060434420008

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention