MAUDE Adverse Event Report: QURA S.R.L. QUANTUM PERFUSION DUAL LUMEN CANNULA 27F; DUAL LUMEN CANNULAE

Model Number	DL27F-VO
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
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.Patient adequately supported.
Event or Problem Description
Received a call that they experience a fracture to a 27fr dual lumen cannula.Cannula had been in for 7 days.Patient also has a heartmate 3 lvad.With fracture of the cannula, the system entrained air.Cannula was pulled and patient placed on dobutamine for right side support.Patient adequately supported.
Event or Problem Description
Received a call that they experience a fracture to a 27fr dual lumen cannula.Cannula had been in for 7 days.Patient also has a heartmate 3 lvad.With fracture of the cannula, the system entrained air.Cannula was pulled and patient placed on dobutamine for right side support.Patient adequately supported.
Additional Manufacturer Narrative
Additional information related to the event is attached.

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA 27F
• Common Device Name: DUAL LUMEN CANNULAE
• 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: 16960947
• Report Number: 3016746283-2023-00004
• Device Sequence Number: 5224902
• Product Code: DWF
• UDI-Device Identifier: 08051160300808
• UDI-Public: 08051160300808
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: 221353
• 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): 06/16/2023

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: 10/06/2024
• Device Model Number: DL27F-VO
• Device Catalogue Number: DL27F-VO
• Device Lot Number: E003012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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: HEARTMATE 3 LVAD; HEARTMATE 3 LVAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 76 KG