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	Restricted Flow rate (1248)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information related to the event will be available after investigation of returned device, which would be addressed in a follow-up report.
Event or Problem Description
(b)(6), ccp called regarding an issue that they had with a cp22-vt, np1001865 centrifugal drive, ph6003247.The goal flow for the patient was 0.5 lpm, however, the highest flow they were able to achieve was 15 lpm no matter how high they turned up the rpms.The highest outlet pressure they achieved was 112 mmhg, and the inlet pressure was around -40 mmhg.They thought it could have been the cannulation, but when they did a circuit change to a biomedicus pump, they were able to achieve the goal flows.They did not report any alarm or alerts at the time.
Additional Manufacturer Narrative
No investigation can be possible due to accidental disposal of the complained device.Considering this is the first case with this claimed issue and the fact the procedure was completed without consequences for the patient, no further actions have deemed required.
Event or Problem Description
The user reported an issue with a cp22-vt.The goal flow for the patient was 0.5 lpm, however, the highest flow they were able to achieve was 15 lpm no matter how high they turned up the rpms.The highest outlet pressure they achieved was 112 mmhg, and the inlet pressure was around -40 mmhg.They thought it could have been the cannulation, but when they did a circuit change to a biomedicus pump, they were able to achieve the goal flows.They did not report any alarm or alerts at the time.

• 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: 23231220
• Report Number: 3016746283-2025-00010
• Device Sequence Number: 12908448
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: (01)08051160300624(11)240531(17)260531(10)G001619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Expiration Date: 05/31/2026
• Device Model Number: CP22V-VT
• Device Lot Number: G001619
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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: Required Intervention
• Patient Sex: Unknown