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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the customer after use; therefore, it was not possible to perform an investigation on the returned unit.No patient harm or adverse effects were reported, and the leakage was contained without further consequences.Similar events will continue to be monitored through the post-market surveillance process.
Event or Problem Description
Blood noted in glycol compartment of hex - appeared to be a fault in the seam line between the glycol compartment and the blood channel.Did not appear to rupture, blood appeared to be contained.Clinician discarded the hex following the procedure.

• 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 SRL; 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: 25213370
• Report Number: 3016746283-2026-00009
• Device Sequence Number: 16060574
• Product Code: DTR
• UDI-Device Identifier: 18051160302205
• UDI-Public: (01)18051160302205(11)251105(17)271105(10)H000950
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 05/19/2026

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
• Device Model Number: HX55V-S0W
• Device Lot Number: H000950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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