MAUDE Adverse Event Report: Spectrum Medical S.r.l. Quantum Perfusion Blood Oxygenator VT200-E1

Model Number	VT200-E1
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information related to the event will be available after investigation of returned device, which could be addressed in a follow-up report.
Event or Problem Description
(b)(6) received 3 vt200's with lot number j000078.Unfortunately, they used all 3 prior to us letting them know of the leaking possibility, and all three were leaking, one being on a patient.2 were thrown away, but they do still have one that was removed from a primed circuit due to leaking.

• Brand Name: Quantum Perfusion Blood Oxygenator VT200-E1
• Common Device Name: Blood Oxygenator
• 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: 25276083
• Report Number: 3016746283-2026-00010
• Device Sequence Number: 9157059
• Product Code: DTZ
• UDI-Device Identifier: 08051160300679
• UDI-Public: (01)08051160300679(11)260209(17)28020(10)J000078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203424
• 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: Modification/Adjustment,Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2026

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: VT200-E1
• Device Lot Number: J000078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/25/2026
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 05/01/2026; 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/15/2026; 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2026
• 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