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

Catalog Number 627308302

Device Problems Break (1069); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information has been provided.The complained circuit has been requested and not yet returned to livanova arvada (manufacturer).Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc.Has received a report that, during a procedure, the tubing presented a split on connector.The tubing was cut out and procedure completed with no issue.

Manufacturer Narrative

The photographic evidence provided by the customer confirmed the presence of a cut in the tubing of the revolution outlet pump under the tie band.No disconnection occurred.No impact on the patient.The dhr review confirmed the circuit was released conforming to product specifications.The lot was made of 22 units and only one was claimed for this issue.Analysis of livanova complaint database did not identify any other similar event.Therefore, the case is an isolated event.The complained unit was not made available for investigation as it was disposed by the customer.It was not possible to clarify if the defect occurred during the procedure or if was un-noticed during the unpacking.Livanova investigation could not identify the root cause.Therefore, a manufacturing issue could not be excluded since it was not possible to confirm whether the cut was related to weakness of the tubing or to a human error caused by the livanova manufacturing operator cutting the tubing during the assembly.The risk is acceptable.Livanova will maintain monitoring the market.H3 other text : device not available.

Event Description

See initial report.

• Brand Name: 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: 12039047
• MDR Text Key: 257726741
• Report Number: 1718850-2021-00034
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622136245
• UDI-Public: (01)00803622136245(240)627308302(17)230430(10)2110500036
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 627308302
• Device Lot Number: 2110500036
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1