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

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
• 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: 14653110
• MDR Text Key: 301987761
• Report Number: 3016746283-2022-00004
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR
• Patient Sex: Male