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	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported that there was thrill heard by the patient coming from the 31 fr dl cannula.The thrill was occurring during manipulation of the cannula.Small amount micro-bubbles were observed entraining into the circuit.No actions were made by the team at this point of the evening and decided to support the cannula through the night.On (b)(6) 2022 upon my arrival at the hospital, the patient was taken electively to the or for cannula exchange.The exchange happened without issues.Of note: 1.Cannula has been in place for 47 days without manipulation.Cannulation (b)(6) 2022 at 14:08.2.The patient has been ambulating for several weeks.3.No alcohol was used per standard care procedures (chg applicators).Cannula notes: 1.Per xxxxxx xxxxx, at site of issue, sutures were used to hold cannula.2.No heparin was used on patient.3.Large clots noted in rv ports.4.Tip of cannula cut per institutional preference.

• 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: 14516865
• Report Number: 3016746283-2022-00003
• Device Sequence Number: 5628923
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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 Expiration Date: 12/19/2022
• Device Model Number: DL31F-V0
• Device Catalogue Number: DL31F-V0
• 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: 05/10/2022
• Initial Report FDA Received Date: 05/26/2022
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 56 KG