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

Model Number	CP37V-V0
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cp37 pumphead cavitating significant air during de-airing of primed hlm.Attempts to de-air resulted in tiny champagne bubble formation originating from the centrifugal pump.No noise or cracks/visible damage to pumphead.Pressurized circuit to test for leak, but no leak noted.Swapped out for new pumphead and the issue disappeared.
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.Because the issue was detected during the de-airing of primed hlm, the patient was not involved; moreover, the health effect clinical code assigned represents a worst-case scenario with respect to the present event.
Event or Problem Description
Cp37 pumphead cavitating significant air during de-airing of primed hlm.Attempts to de-air resulted in tiny champagne bubble formation originating from the centrifugal pump.No noise or cracks/visible damage to pumphead.Pressurized circuit to test for leak, but no leak noted.Swapped out for new pumphead and the issue disappeared.
Additional Manufacturer Narrative
For the result of the investigation activities please refer to investigation report attached (nhcx0026_investigation_on_rmd).Because the issue was detected during the de-airing of primed hlm, the patient was not involved; moreover, the health effect clinical code assigned represents a worst-case scenario with respect to the present event.

• 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: 21811739
• Report Number: 3016746283-2025-00002
• Device Sequence Number: 18351484
• Product Code: KFM
• UDI-Device Identifier: 08051160300617
• UDI-Public: (01)08051160300617(17)260620(10)G001702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/08/2025

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: 06/20/2026
• Device Model Number: CP37V-V0
• Device Lot Number: G001702
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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