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

Catalog Number 044035402

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group italia manufactures the cobe smarxt tubing and connectors (b)(6).The incident occurred in (b)(6).The involved circuit has been discarded and thus it has not been made available for investigation.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.The present mfr report number was submitted on february 20, 2020 as mfr report number 1718850-2020-00004 initial report.The first and second acks were successfully processed (coreid: (b)(4)).The third ack failed as it contained the error message that there was duplicate report.Investigation confirmed that the report number 1718850-2020-00004 was indeed a duplicate due to an error while creating an importer report number.To avoid reoccurrence, the relevant personal has been retrained on the procedure for importer report submission and the present report has been submitted with a different mfr report number.

Event Description

Livanova usa inc has received a report that, upon rewarming during a procedure, the tubing with connects the pump outlet with the oxygenator inlet disconnected by the oxygenator side.The perfusionist pushed the tubing back on the oxygenator inlet and recorded the circuit to de air and resume bypass.Approximately 600cc of patient blood volume were lost and medical team elected to administer 2 units of blood bank.The patient was extubated and is recovering as expected.There is no report of any patient injury.

Manufacturer Narrative

H.10: the complained circuit (disconnected tubing and revolution pump) was disposed by the user and thus not available for investigation.No photographic evidence of the claimed problem was provided to livanova a review of the dhr did not identify any deviation, non-conformity or material scrap/requests relevant to the reported issue.No other similar complaint was received for the claimed lot.Analysis of the technical documentation of the circuit confirmed that the connection that was reported to have disconnected is provided to the customer not assembled.The connection is done by the customer during the set up of the circuit.Despite no evidence was provide to livanova, the claimed issue was confirmed based on event description.According to investigation, the claimed disconnection is not ascribable to any device problem.Livanova believes the most probable root cause was a suboptimal connection of the tubing during setup of the circuit.To prevent further re-ocurrence, the technical drawing has been updated in agreement with the customer and the circuit will start to be supplied to customer with the connection from pump to oxygenator already preconnected by manufacturer and fixed with a tie.Livanova will keep monitoring the market for similar events.The present mfr report number was submitted on (b)(6)2020 as mfr report number 1718850-2020-00004 follow up 1 report.The first and second acks were successfully processed (coreid: ci1588166814574.231889@fdsuv08653_te2).The third ack failed as it contained the error message that there was duplicate report.Investigation confirmed that the report number 1718850-2020-00004 was indeed a duplicate due to an error while creating an importer report number.To avoid reoccurrence, the relevant personal has been retrained on the procedure for importer report submission and the present report has been submitted with a different mfr report number (b)(4).

• 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
• MDR Report Key: 9989291
• MDR Text Key: 188872204
• Report Number: 1718850-2020-00018
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622140495
• UDI-Public: (01)00803622140495(240)044035402(17)211231(10)1934500077
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 044035402
• Device Lot Number: 1934500077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention