MAUDE Adverse Event Report: QURA S.R.L. QUANTUM DUAL LUMEN CANNULA 27F; DUEL LUMEN CANNULA

Model Number	DL27F-VO
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information the hospital had provided (device photos, xray, other data) for the investigation made it possible to identify a probable cause of the issue.The mechanical breakage appears to be due to a flexion at the area where the cannula started leaking.
Event or Problem Description
27fr dual lumen cannula noted to be leaking below bifurcation of cannula.Patient had been on for almost a month.Cannula was replaced with another 27fr dual lumen cannula without issue.Positive pressure measuring 350 on leaking cannula.No suture was at the area where the cannula starting leaking, perfusionist said it looked more like a point of flexion.

• Brand Name: QUANTUM DUAL LUMEN CANNULA 27F
• 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: 16213214
• Report Number: 3016746283-2023-00001
• Device Sequence Number: 17235779
• Product Code: DWF
• UDI-Device Identifier: 08051160300808
• UDI-Public: 8051160300808
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: DL27F-VO
• Device Catalogue Number: DL27F-VO
• Device Lot Number: E002593
• 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: 12/27/2022
• Initial Report FDA Received Date: 01/20/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 109 KG