MAUDE Adverse Event Report: LIVANOVA USA INC TUBING, PUMP, CARDIOPULMONARY BYPASS; COBE SMARXT TUBING AND CONNECTORS

Catalog Number 044015600

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The involved circuit is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

While on bypass, arterial line from revolution pump head to inspire oxygenator disconnected due to high pressure event.Pump flow to patient was stopped to re-attach line, then restarted to deair.Flow to patient was establish after line determined clear by perfusionist.The patient was administered of blood bank.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

The complained circuit was not available and therefore could not be returned to livanova.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.Based on livanova investigation, a potential root cause of the tubing disconnection could be an alteration of the chemical/mechanical characteristics of the tubings.The risk associated to the event is acceptable.No specific action is deemed necessary.Livanova will keep monitoring the market.Device not available.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: COBE SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10466779
• MDR Text Key: 209775198
• Report Number: 1718850-2020-00037
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Catalogue Number: 044015600
• Device Lot Number: 2003800024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/27/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1