BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

    MDR report key: 23603338 · Received November 20, 2025

    Report

    Report Number
    3016746283-2025-00017
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 24, 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

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

    Additional Manufacturer Narrative · 0

    REFER TO QHCX0501_INVESTIGATION_RMD_PRELIMINARY FOR PARTIAL CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION AND DEFECT IDENTIFICATION: TWO SYMMETRICAL HOLES WERE FOUND IN THE CENTRAL AREA OF THE DEVICE WHERE THE KNURLED PATTERN CHANGES DIRECTION. SCANNING ELECTRON MICROSCOPY (SEM): SEM IMAGING WAS USED TO CHARACTERIZE THE DIMENSIONS OF THE HOLES (APPROXIMATELY 100 MICRONS) AND TO OBTAIN DETAILS OF THE METAL SHEET SURFACE NEAR THE HOLES. FLUID TEST RESULTS: TESTING CONFIRMED THAT EVEN WITH THE HOLES PRESENT, UNDER WORST-CASE CONDITIONS, FLOW OCCURS FROM BLOOD TO HTF, ENSURING THAT NO HTF CAN ENTER THE BLOOD COMPARTMENT. THIS IS DUE TO THE FROSTY DESIGN: HTF IS DRAWN OUT OF THE HEAT EXCHANGER, SO THE PRESSURE INSIDE THE HTF COMPARTMENT IS ALWAYS NEGATIVE, WHILE THE BLOOD COMPARTMENT IS ALWAYS UNDER POSITIVE PRESSURE. AS A RESULT, THE PRESSURE DIFFERENTIAL ACROSS THE METAL SHEET GUARANTEES THAT ONLY BLOOD CAN ENTER THE HTF COMPARTMENT, NOT VICE VERSA. A FINAL AND COMPLETE REPORT WILL BE RELEASED WHEN ALL THE RESULTS WILL BE AVAILABLE.

    Description of Event or Problem · 0

    AFTER CPB AND DURING DEPRIMMING THE CUSTOMER NOTICED THAT THE GLYCOL HAD TURNED IN GREY. BECAUSE THIS EVENT HAPPENED END OF THE CASE, PRODUCT WERE NOT REPLACED. CONSEQUENCES: RESIDUAL BLOOD HAS BEEN WASHED BY CELLSAVER.

    Description of Event or Problem · 0

    AFTER CPB AND DURING DEPRIMMING THE CUSTOMER NOTICED THAT THE GLYCOL HAD TURNED IN GREY. BECAUSE THIS EVENT HAPPENED END OF THE CASE, PRODUCT WERE NOT REPLACED. CONSEQUENCES: RESIDUAL BLOOD HAS BEEN WASHED BY CELLSAVER.

    Description of Event or Problem · 0

    AFTER CPB AND DURING DEPRIMMING THE CUSTOMER NOTICED THAT THE GLYCOL HAD TURNED IN GREY. BECAUSE THIS EVENT HAPPENED END OF THE CASE, PRODUCT WERE NOT REPLACED. CONSEQUENCES: RESIDUAL BLOOD HAS BEEN WASHED BY CELLSAVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176412 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