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
Pt supported on vv ecmo with a dlca since 1/31.The team reported an event today 5/19 where the cannula separated at the venous y.They attempted to tie band the connection but were unable to secure and so the patient was recannulated to va ecmo.Patient welfare information - off ecmo - received a bilateral lung transplant.
Additional Manufacturer Narrative
Moved warning to first page of the ifu: do not allow alcohol, alcohol-based liquids, ethers, halogenated liquids or corrosive solvents to come into contact with the device.This would cause damage such as to compromise the integrity and functionality of the device.

• 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: 15354950
• Report Number: 3016746283-2022-00005
• Device Sequence Number: 6277564
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/05/2022
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 91 KG