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	10/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information related to the event will be available after the investigation of the returned device, which could be addressed in a follow-up report.According to available information, no consequences for the patient.
Event or Problem Description
Propeller on the cp22 seems to be off-center.This was noticed after the clinician reported increased hemolysis in the patient that had been on less than 24 hrs.Change out the cp22 and that resolved the patients hemolysis issues.After the pump change out, the clinician saw a thrombus on the bearing of the pump that was just changed out.
Additional Manufacturer Narrative
Follow-up information - december 2023: investigation activities performed on returned device.Refer to investigation report attached (er_r&d_cp_23_scc404).
Event or Problem Description
Propeller on the cp22 seems to be off-center.This was noticed after the clinician reported increased hemolysis in the patient that had been on less than 24 hrs.Change out the cp22 and that resolved the patients hemolysis issues.After the pump change out, the clinician saw a thrombus on the bearing of the pump that was just changed out.

• 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: 18235835
• Report Number: 3016746283-2023-00006
• Device Sequence Number: 3176311
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: 08051160300624
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 12/22/2023

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: 02/22/2025
• Device Model Number: CP22V-VT
• Device Lot Number: F000150
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown