MAUDE Adverse Event Report: QURA SRL. QUANTUM DUAL LUMEN CANNULA 31F; DUEL LUMEN CANNULA

Model Number	DL31F-V0
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was place on ecmo with the cannula in question, estimated date is (b)(6) 2022.The nurse manager for their ecmo icu unit notified me that their 31 fr dual lumen cannula "de coupled" while on a patient.The patient was sitting up in bed when this happened.The drainage hub of the dual lumen cannula came undone and disconnected from the cannula.The ecmo circuit filled with air.The ecmo specialist were very quick to react and clamped the circuit.The patient was very stable during this time.They were able to re cannulate the patient with a different cannula.The patient is doing well on ecmo now and noted no significant blood loss or significant clinical deficiencies.

• Brand Name: QUANTUM DUAL LUMEN CANNULA 31F
• Common Device Name: DUEL LUMEN CANNULA
• Manufacturer (Section D): QURA SRL.; 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: 14335282
• Report Number: 3016746283-2022-00002
• Device Sequence Number: 12328631
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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-V0
• Device Catalogue Number: DL31F-V0
• Device Lot Number: D002352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Race: Asian