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

Catalog Number 627121702

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Neither the unit nor any picture are available for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.

Event Description

Livanova usa inc has been informed that, in two (2) cases, tubing slipped off from the cannulae.The medical team secured the connection with no issue.Neither the unit nor any picture are available.The issue occurred prior to patient involvement.

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.H3 other text : device not available.

Event Description

See initial report.

• 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: 10331203
• MDR Text Key: 203382643
• Report Number: 1718850-2020-00029
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622121555
• UDI-Public: (01)00803622121555(240)627121702(17)211231(10)1934800040
• 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: 06/30/2020

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: 12/31/2021
• Device Catalogue Number: 627121702
• Device Lot Number: 1934800040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/28/2020
• 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