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 Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that patient had been on support for about 30 minutes, when the tie-banded tubing became disconnected from the outlet of the cp22v-vt.Line pressures on the p-out were reading <250mmhg at the time.Both the perfusionist and the ecmo specialist confirmed the tubing was on past the second barb and the tie band was in the proper location and secure.Patient was supported medically and quickly put on another system.
Additional Manufacturer Narrative
Additional information related to the event will be available after completion of investigation activities, which would be addressed in a follow-up report.
Additional Manufacturer Narrative
Additional information related to the event are included in the preliminary investigation report attached (refer to bhcx1210_investigation_rmd_preliminary).Final conclusions will follow in a further follow-up communication.
Event or Problem Description
User reported that patient had been on support for about 30 minutes, when the tie-banded tubing became disconnected from the outlet of the cp22v-vt.Line pressures on the p-out were reading <250mmhg at the time.Both the perfusionist and the ecmo specialist confirmed the tubing was on past the second barb and the tie band was in the proper location and secure.Patient was supported medically and quickly put on another system.
Additional Manufacturer Narrative
For final conclusions, please refer to bhcx1210_investigation_rmd_final.
Event or Problem Description
User reported that patient had been on support for about 30 minutes, when the tie-banded tubing became disconnected from the outlet of the cp22v-vt.Line pressures on the p-out were reading <250mmhg at the time.Both the perfusionist and the ecmo specialist confirmed the tubing was on past the second barb and the tie band was in the proper location and secure.Patient was supported medically and quickly put on another system.

• 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: 24003631
• Report Number: 3016746283-2025-00024
• Device Sequence Number: 13361675
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/23/2026

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: H000170
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/06/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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