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

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	02/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up communication with the hospital, the bedside specialist noticed a small amount of air entrainment in the circuit.They checked the circuit and crrt circuit for leaks and found nothing.They took the crrt circuit away and it was still entraining air.After that they changed out the entire circuit.Soon after, they turned the patient to clean him.At that point, the entire circuit filled with air.The patient was coded for about 45 minutes and emergently converted to fem - fem va ecmo.After examining the cannula they discovered that it decoupled at the bifurcation.This patient was doing some daily pt, sitting up on the side of the bed, and attempting to stand some.You will notice in the picture below that they have foam pads on the tubing.That was to protect the patient's ears from rubbing.The manufacturer investigation reproduced the event in the laboratory.It is a high probability that the root cause could be identified as "chloraprep applicator that contains 70% isopropanol" to clean the insertion area of the cannula and skin multiple times over 16 days with an accidental exposure to the bonding of the drainage lumen and y hub connector.The patient is alert and responding to commands.
Event or Problem Description
31fr quantum dual lumen cannula was in place on a patient providing support.The cannula became decoupled outside of the patient, near the "metal fingers" where the wire reinforcement area stops.The patient was resuscitated on va ecmo support and phyiscian reported that the patient appears to be intact.Hospital is performing internal risk management process, then the device would be available for customer return.
Additional Manufacturer Narrative
Through follow-up communication with the hospital, the bedside specialist noticed a small amount of air entrainment in the circuit.They checked the circuit and crrt circuit for leaks and found nothing.They took the crrt circuit away and it was still entraining air.After that they changed out the entire circuit.Soon after, they turned the patient to clean him.At that point, the entire circuit filled with air.The patient was coded for about 45 minutes and emergently converted to fem - fem va ecmo.After examining the cannula they discovered that it decoupled at the bifurcation.This patient was doing some daily pt, sitting up on the side of the bed, and attempting to stand some.You will notice in the picture below that they have foam pads on the tubing.That was to protect the patient's ears from rubbing.The manufacturer investigation reproduced the event in the laboratory.It is a high probability that the root cause could be identified as "chloraprep applicator that contains 70% isopropanol" to clean the insertion area of the cannula and skin multiple times over 16 days with an accidental exposure to the bonding of the drainage lumen and y hub connector.The patient is alert and responding to commands.
Event or Problem Description
31fr quantum dual lumen cannula was in place on a patient providing support.The cannula became decoupled outside of the patient, near the "metal fingers" where the wire reinforcement area stops.The patient was resuscitated on va ecmo support and phyiscian reported that the patient appears to be intact.Hospital is performing internal risk management process, then the device would be available for customer return.

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA 31F
• Common Device Name: DUAL LUMEN CANNULA 31F
• 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: 13575707
• Report Number: 3016746283-2022-00001
• Device Sequence Number: 20215487
• 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): Y
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model 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: 02/12/2022
• Initial Report FDA Received Date: 02/22/2022
• 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: Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White