MAUDE Adverse Event Report: LIVANOVA USA, INC.; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

No effect to the patient.Initiated bypass on patient, clamped and started surgical portion of procedure.On bypass, 47 minutes in, i noticed a small drip coming from the outlet of the oxygenator.Placed an additional tie band on the outlet tubing of the oxygenator after i found the tie band that was there from the manufacturer was loose and ineffective.Tubing is supposed to be bonded as well.Manufacturer notified.Leak did stop.

• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 7731336
• MDR Text Key: 115390203
• Report Number: 7731336
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1