BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUMP CONSOLE

    MDR report key: 8797017 · Received July 17, 2019

    Report

    Report Number
    3006073153-2019-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 12, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS DEEMED LOW RISK TO THE PATIENT AND AN UPDATE WOULD BE DEPLOYED AT THE NEXT CUSTOMER SERVICE. 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. PLEASE SEE THE (B)(4) INVESTIGATION OF SCC-85 AND (B)(4) VERIFICATION OF FIXES TO SOLARIS FIRMWARE FOR SCC-085 REPORTS. (B)(4).

    Description of Event or Problem · 1

    SPECTRUM MEDICAL RECEIVED A REPORTED INCIDENT ON (B)(6) 2019. THIS INVOLVED THE QUANTUM PUMP CONSOLE SYSTEM SHUTTING DOWN WHEN PREPARING TO WEAN PATIENT OFF BYPASS. THE PERFUSION SYSTEM IDENTIFIER FROM (B)(6) FOR THIS PARTICULAR HLM IS HLM-04, IDENTIFIED VIA THE SYSTEM MONITOR, QWS (B)(4), AND THE POWER SUPPLY, QPS (B)(4). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590889 QUANTUM PUMP CONSOLE HEART LUNG MACHINE DTQ SPECTRUM MEDICAL LTD. 05060434420008

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention