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

Model Number	HX55W-S0
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported signs of damage to the sterile primary packaging (blister) before use.No patient was involved.
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
Detailed investigation report with corresponding conclusions is attached (refer to (b)(4)).
Event or Problem Description
User reported signs of damage to the sterile primary packaging (blister) before use.No patient was involved.

• Brand Name: QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8
• 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: 23614817
• Report Number: 3016746283-2025-00018
• Device Sequence Number: 21354932
• Product Code: DTR
• UDI-Device Identifier: 08051160301171
• UDI-Public: (01)08051160301171(11)250206(17)270206(10)H000081
• 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
• Report Date (Section B): 02/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX55W-S0
• Device Lot Number: H000081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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