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

Catalog Number 627389201

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova usa inc manufactures the convenience pack (b)(4).The incident occurred in (b)(4), united states.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova inc has received a report that, during a bypass, the tubing that connects revolution pump to a non livanova oxygenator disconnected.The perfusionist quickly reconnected the tubing.There is no report of any patient injury.On (b)(6) 2020, livanova has been informed that the connection was secured with a tie-wrap.Moreover, the circuit had been set up for almost 30 days before it was used in a procedure.

Event Description

See initial report.

Manufacturer Narrative

The complained circuit 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.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10520633
• MDR Text Key: 209775666
• Report Number: 1718850-2020-00039
• 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: 09/11/2020

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: 02/28/2023
• Device Catalogue Number: 627389201
• Device Lot Number: 2005700035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1