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

Model Number	CP22V-VT
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cp22 disposable port on the inlet side appears to have cut out during the run.Perfusionist states that the inlet pressure decreased to -700, causing the pump to stop before the inlet pressure in the guage bar went completely blank.
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.
Additional Manufacturer Narrative
The analysis revealed that a pin in the inlet sensor is bent, causing the impossibility to read the pressure value.Records of the analyses carried out in the clean room before device's release, revealed that the two sensors performed correctly when tested.Since the device passed this control, it can be assumed that the pin was damaged during clinical procedure (refer to bhcx763_investigation_rmd).
Event or Problem Description
Cp22 disposable port on the inlet side appears to have cut out during the run.Perfusionist states that the inlet pressure decreased to -700, causing the pump to stop before the inlet pressure in the guage bar went completely blank.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGR
• 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: 23025462
• Report Number: 3016746283-2025-00008
• Device Sequence Number: 9216759
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: (01)08051160300624(11)250225(17)270225(10)H000145
• 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): 10/16/2025

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: H000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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