MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

Model Number	CP22V-VT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/19/2025
Type of Reportable Event	Death
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.
Event or Problem Description
User reported that three cases in a row have experienced high pfh (plasma free hemoglobin).It was reported that all three were different lot numbers.Unknown the previous two lot numbers for this report.The hospital recently changed lab machines for measuring pfh.New machine registered much higher.They were not able to compare on previous cases, but this case they did.Pfh new machine 200 and 230 and old method was 50 and 74 respectively.Case before (two samples) with new machine 350 and 1040.Case 3 before that two sample 220 and 250.They use medtronic tubing and eos oxygenators.Rpm was reported to be 3500-4000 to maintain a flow of 150 ml/kg (flow of 0.55 lpm).Seems elevated, but the user did not identify any reason for it.Line pressures 190-220 mmhg.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS
• Common Device Name: CENTRIFUGAL BLOOD PUMP
• 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: 23887691
• Report Number: 3016746283-2025-00026
• Device Sequence Number: 4706162
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: (01)08051160300624(11)241113(17)261113(10)H000460
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K201320
• 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
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: CP22V-VT
• Device Lot Number: H000460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 11/13/2024
• 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: Death
• Patient Sex: Unknown