MAUDE Adverse Event Report: QURA S.R.L. QUANTUM DUAL LUMEN CANNULA 31F; DUEL LUMEN CANNULA

Model Number	DL31F-VO
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Quantum dual lumen venous."i just wanted to bring to your attention an issue we had today with a spectrum cannula.One of our current patients, began entraining air from the venous side if the neck or cannula were manipulated in any way.We exchanged the cannula in the operating room and the attached video is of the spectrum cannula once it was removed from the patient.".

• Brand Name: QUANTUM DUAL LUMEN CANNULA 31F
• Common Device Name: DUEL LUMEN CANNULA
• 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: 14653110
• Report Number: 3016746283-2022-00004
• Device Sequence Number: 4764582
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DL31F-VO
• Device Catalogue Number: DL31F-VO
• Device Lot Number: D002352
• 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: 05/19/2022
• Initial Report FDA Received Date: 06/10/2022
• 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 Age: 52 YR
• Patient Sex: Male