MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37 WITH INTEGR; CENTRIFUGAL BLOOD PUMP WITH INTEGRATED SENSORS

Model Number	CP37V-VT
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the results of the investigation activities please refer to investigation report attached ("bgcx0272_investigation_rmd").Because the problem was detected during the device priming phase, 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
When priming a new cps circuit, micro air consistently noted.After further investigation, air noted to be pulling across from the p in port on this pump.Disposable exchanged with new one, no issues noted.
Additional Manufacturer Narrative
The investigation of the returned device is ongoing, no further information is available regarding the event, which could be addressed in a follow-up report.Because the issue was detected during the device priming phase, there was no patient involvement.
Event or Problem Description
When priming a new cps circuit, micro air consistently noted.After further investigation, air noted to be pulling across from the p in port on this pump.Disposable exchanged with new one, no issues noted.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP37 WITH INTEGR
• Common Device Name: CENTRIFUGAL BLOOD PUMP WITH INTEGRATED SENSORS
• 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: 21215847
• Report Number: 3016746283-2024-00008
• Device Sequence Number: 16975755
• Product Code: KFM
• UDI-Device Identifier: 18051160302663
• UDI-Public: 18051160302663
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233091
• 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): 03/14/2025

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: 09/03/2026
• Device Model Number: CP37V-VT
• Device Lot Number: G001863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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