MAUDE Adverse Event Report: SPECTRUM MEDICAL/QURA SRL QUANTUM PERFUSION DUAL LUMEN CANNULA 31F; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number DL31F-V0

Device Problems Loss of or Failure to Bond (1068); Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

When the perfusionist was connecting the quantum arterial limb to the new ecmo circuit, the factory bonded connection on the venous limb was loose and came disconnected.Few months back, our hospital was notified from the manufacturer about events at an outside hospital and recommended the avoidance of alcohol use.No official fda recall issued.Described as alcohol degraded the adhesive in the bounding cannula.

Event Description

When the perfusionist was connecting the quantum arterial limb to the new extracorporeal membrane oxygenation (ecmo) circuit, the factory bonded connection on the venous limb was loose and came disconnected.Few months back, our hospital was notified from the manufacturer about events at an outside hospital and recommended the avoidance of alcohol use with reference to the instructions for use (ifu) of the device.Per staff, reeducation was immediately shared, and signage was posted as additional reminders to avoid all alcohol with the device.

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA 31F
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL/QURA SRL; 481 munn road suite; suite 180; fort mill SC 29715
• MDR Report Key: 15347192
• MDR Text Key: 299153943
• Report Number: 15347192
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/26/2022,06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DL31F-V0
• Device Catalogue Number: DL31F-V0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1