MAUDE Adverse Event Report: Spectrum Medical S.r.l. Quantum SuperPAC CPB - 1/2 Venous with AV Bridge; Cardiopulmonary bypass system tubing set

Catalog Number	SPC200A-D2
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complained device has been requested to conduct the investigation.We are waiting for its return.Further actions will be evaluated once the investigation will be completed.
Event or Problem Description
The user reported that during a trial, a significant air ingress through the venous line led to a massive air lock within the reservoir.In detail: bypass was started (surgery with cooling to 32 degrees celcius).From the beginning: a lot of air through the venous line.Significant air ingress via the venous line.Resulting air lock within the reservoir.Air lock caused separation of the upper reservoir volume.Continuous pump stops occurred at the lower-level sensor due to trapped volume in the upper reservoir.System function was repeatedly interrupted.Multiple attempts to resolve the air lock were unsuccessful.Even vacuum application did not restore functionality.No recovery of normal system operation was possible.As a result, qps had to be replaced.No harm occurred to the patient.Nirs remained stable the whole time.

• Brand Name: Quantum SuperPAC CPB - 1/2 Venous with AV Bridge
• Common Device Name: Cardiopulmonary bypass system tubing set
• 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: 25407818
• Report Number: 3016746283-2026-00012
• Device Sequence Number: 13373172
• Product Code: DTZ
• UDI-Device Identifier: 18051160303134
• UDI-Public: (01)18051160303134(11)260116(17)280116(10)J000032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/27/2026

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 Catalogue Number: SPC200A-D2
• Device Lot Number: J000032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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