MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37

Model Number	CP37V-V0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	08/04/2025
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
Got an urgent call while on bypass asking if the max rpm's for the cp37 was 4000.Could not flow above 2.5 liters with a normal line pressure.Went on fine with normal flows but when lowered the flow to apply the cross clamp and came back up could not come to full flow.Proceeded to hand crank and achieved normal flow.Switched motors with same low flow high rpm results.After several minutes they were able to come up to a normal flow.Act was good and clamp was also re-adjusted but didn't help.I discussed with them the possibilities of: 1.Seating of disposable 2.Clot impeding flow into the pump head 3.Problem with their line pressure transducer 4.Possible problem with circuit before where they measure line pressure.
Additional Manufacturer Narrative
Tests performed in spectrum medical lab have demonstrated the proper functioning of the device.Without examining the entire circuit setup, it's impossible to know all the possibilities contributing to the reported conditions (refer to bhcx0742_investigation_rmd attached for details).We'll keep on register any similar events coming from the market to verify and prevent the issue.
Event or Problem Description
Got an urgent call while on bypass asking if the max rpm's for the cp37 was 4000.Could not flow above 2.5 liters with a normal line pressure.Went on fine with normal flows but when lowered the flow to apply the cross clamp and came back up could not come to full flow.Proceeded to hand crank and achieved normal flow.Switched motors with same low flow high rpm results.After several minutes they were able to come up to a normal flow.Act was good and clamp was also re-adjusted but didn't help.I discussed with them the possibilities of: 1.Seating of disposable.2.Clot impeading flow into the pump head.3.Problem with their line pressure trandsducer.4.Possible problem with circuit before where they measure line pressure.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37
• 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: 22921738
• Report Number: 3016746283-2025-00007
• Device Sequence Number: 13051907
• Product Code: KFM
• UDI-Device Identifier: 08051160300617
• UDI-Public: (01)08051160300617(11)241008(17)261008(10)G001924
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K202169
• 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: CP37V-V0
• Device Lot Number: G001924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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