MAUDE Adverse Event Report: LIVANOVA USA, INC. UNKNOWN; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 627360001

Device Problems Air Leak (1008); Crack (1135)

Patient Problems Air Embolism (1697); Hypoxia (1918)

Event Date 01/21/2018

Event Type  malfunction  

Event Description

Ecmo pressure monitor tubing cracked a lure lock/tubing connection which then caused air to enter ecmo circuit.Air ended up in arterial limb of circuit resulting in patient being clamped off of vv ecmo support to prevent air emboli from entering heart/lungs.Patient was off ecmo for approximately 5 minutes while equipment was repaired and air removed from the circuit so that flow could be safely resumed to the patient.During time off ecmo patient experienced hypoxic episode.Once flow resumed, patient vs recovered and no obvious sequelae from event noticed.The damaged section of ecmo circuit was replaced and the remainder of ecmo circuit in use and functioning without issue.The tubing that was damaged comes as a part of a tubing pack from sorin.

• Brand Name: UNKNOWN
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 7288802
• MDR Text Key: 100678241
• Report Number: 7288802
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018,02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 627360001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR