BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

    MDR report key: 23825787 · Received December 17, 2025

    Report

    Report Number
    3016746283-2025-00025
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    December 12, 2025
    Report Date
    May 11, 2026
    Manufacturer
    SPECTRUM MEDICAL S.R.L.
    Product Code
    DTR
    UDI-DI
    08051160300501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO QHCX0561_INVESTIGATION_RMD_PRELIMINARY FOR PARTIAL CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    USER REPORTED THAT GLYCOL SLIGHTLY CHANGED ITS COLOR AFTER FINISHING THE BYPASS, SUSPECTING BLOOD LEAKAGE. NO HARM OCCURRED FOR THE PATIENT.

    Description of Event or Problem · 0

    USER REPORTED THAT GLYCOL SLIGHTLY CHANGED ITS COLOR AFTER FINISHING THE BYPASS, SUSPECTING BLOOD LEAKAGE. NO HARM OCCURRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46877 QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 STANDARD HEAT EXCHANGER DTR SPECTRUM MEDICAL S.R.L. HX55V-S0 G002192 08051160300501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention