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

Model Number DL31F-VO

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Air Embolism (1697)

Event Date 05/19/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 305608680
• Report Number: 3016746283-2022-00005
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 91 KG