MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W

Model Number	HX55V-S0W
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported a blood to glycol leak during the case.No adverse consequences occurred for the patient.
Additional Manufacturer Narrative
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
Preliminary findings available in current follow-up 001 report: 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 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.Further testing is ongoing to gather more details that will help identify the root cause of the problem.These tests include: analysis of metal sheets performed by an external lab; study of current/voltage versus hole formation.A final and complete report will be released when all the results will be available.
Event or Problem Description
User reported a blood to glycol leak during the case.No adverse consequences occurred for the patient.
Additional Manufacturer Narrative
Preliminary analysis performed revealed the presence of one hole in the metal sheet.Nevertheless, the root cause of this issue has not been identified.Additional investigations are ongoing.Therefore, an additional follow-up communication will be done after completion of investigation activities.
Event or Problem Description
User reported a blood to glycol leak during the case.No adverse consequences occurred for the patient.
Event or Problem Description
User reported a blood to glycol leak during the case.No adverse consequences occurred for the patient.
Additional Manufacturer Narrative
According to the investigation performed, it was confirmed that blood to htf leakage is generated by holes present in the hx55 metal sheet.By combing the results of the investigation, it is possible to state that given the inherent complexity and timescale of the spontaneous corrosion mechanism, hole formation within the timeframe reported by the customer (minutes to hours) would only be plausible in the presence of external accelerating factors that cannot be predictable a priori.Nevertheless, considering the following: for what concern the potential impact on patient safety, even with the holes present in the metal sheet, under worst-case conditions, flow occurs from blood to htf, ensuring that no htf can enter the blood compartment.This is due to the quantum heater-cooler machine 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 viceversa.This represents a safety mechanism acting to protect the patient in case of metal sheet loss of integrity.The instructions for use clearly indicate that the priming procedure must be completed shortly before device use, since prolonged contact with the priming solution may compromise the device's integrity and performance.The malfunctioning of the metal sheet is already considered as potential hazard in the heat exchanger product risk analysis with a benefit-risk ratio still acceptable after implementation of all risk control measures.The actual incidence rate of this kind of issue is currently < 0,1% (0,019%) compared to the estimated value in the risk analysis (<1%) considering the units sold worldwide.For these reasons, no further actions are deemed required.

• Brand Name: QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W
• Common Device Name: STANDARD HEAT EXCHANGER
• Manufacturer (Section D): SPECTRUM MEDICAL S.R.L.; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• Manufacturer (Section G): SPECTRUM MEDICAL S.R.L.; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: raffaella tommasini ; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 23772177
• Report Number: 3016746283-2025-00023
• Device Sequence Number: 9722861
• Product Code: DTR
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K223879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX55V-S0W
• Device Lot Number: H000456
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/13/2025; 11/13/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/09/2026; 04/13/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown