MAUDE Adverse Event Report: QURA S.R.L. QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSOR

Model Number	CP22V-VT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After reviewing data collected from the field (images and the case files) from a preliminary documentary analysis we believe it to be an embolism suctioned into the venous line and deposited into the centrifugal pump acutely.The data on the centrifugal pump measuring the inlet and outlet pressures, as well as rpm and flows, should not gradually decline in performance.The inlet pressures spiked and flow was significantly reduced.Accompanied by the pictures of the deposit it looked like a thrombus that was stringy in formation and ravelled around the rotors, limiting the ability for mechanical performance.No patient information was provided.
Event or Problem Description
Cp22v-vt disposable was changed out due to high hemolysis (high plasma free hemoglobin).After cutting out the old disposable, it was found to have large fibrin strands wrapped in the fins of the pump head.

• Brand Name: QUANTUM PUREFLOW CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSOR
• Common Device Name: CENTRIFUGAL BLOOD PUMP
• Manufacturer (Section D): QURA 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: 16519967
• Report Number: 3016746283-2023-00002
• Device Sequence Number: 2493179
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: 08051160300624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/09/2023

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: 02/19/2024
• Device Model Number: CP22V-VT
• Device Catalogue Number: CP22V-VT
• Device Lot Number: E002442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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