MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

Model Number	CP22V-VT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Refer to investigation report attached (er_r&d_24_003_scc410).
Event or Problem Description
Perfusionist had called with concern that the centrifugal pump cp22v-vt was causing hemolysis.
Additional Manufacturer Narrative
Refer to investigation report attached (b)(4).
Event or Problem Description
Perfusionist had called with concern that the centrifugal pump cp22v-vt was causing hemolysis.

• Brand Name: 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: 18542459
• Report Number: 3016746283-2024-00001
• Device Sequence Number: 9163932
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: 08051160300624
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 03/13/2025
• Device Model Number: CP22V-VT
• Device Lot Number: F000197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 18 FR EOPA ARTERIAL CANNULA.; 18 FR EOPA ARTERIAL CANNULA.; 21 FR ARTERIAL/JUGULAR BIOMEDICUS.; 21 FR ARTERIAL/JUGULAR BIOMEDICUS.; CENTRIFUGAL MOTOR.; CENTRIFUGAL MOTOR.; WORKSTATION.; WORKSTATION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown