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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
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.No patient information was provided.
Event or Problem Description
Clinician called to report that cp22 disposable was changed out due to signs of high hemolysis (high plasma free hemoglobin and rising delta p) after being on ecmo for 4 days.After flushing the old circuit, the pre-side of the oxygenator was covered in hemolytic fibers, which they assumed had come from the pump head.Qws being used at this time was sn#: (b)(4).Clinician is asking us to investigate this disposable for any possible defects to determine whether this developed in the pump head or was drawn in from the patient.A very similar occurence was reported on (b)(6) 2022.
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.No patient information was provided.(b)(6) 2023: investigation report attached - follow-up report.
Event or Problem Description
Clinician called to report that cp22 disposable was changed out due to signs of high hemolysis (high plasma free hemoglobin and rising delta p) after being on ecmo for ~ 4 days.After flushing the old circuit, the pre-side of the oxygenator was covered in hemolytic fibers, which they assumed had come from the pump head.Qws being used at this time was sn(b)(6).Clinican is asking us to investigate this disposable for any possible defects to determine whether this developed in the pump head or was drawn in from the patient.A very similar occurence was reported on (b)(6) 2022.

• 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: 16521305
• Report Number: 3016746283-2023-00003
• Device Sequence Number: 15067513
• 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,Followup
• Report Date (Section B): 04/04/2023

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: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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