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

Catalog Number 627399903

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The complained lot number is unknown.Therefore, also expiration date and udi are unknown.The complained lot number is unknown.Therefore, also device manufacturer date is unknown.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Livanova usa inc has been informed that, during a procedure, the tubing coming out from the revolution centrifugal pump and entering the inspire oxygenator fell off the connector.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.As device lot is unknown, manufacturing date, expiry date and udi are unknown.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.H3 other text : device not available.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10394958
• MDR Text Key: 205477500
• Report Number: 1718850-2020-00034
• 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: 07/25/2020

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 Catalogue Number: 627399903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/19/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1