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

Catalog Number	627308302
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
See initial report.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 12039047
• Report Number: 1718850-2021-00034
• Device Sequence Number: 11811836
• Product Code: DWE
• UDI-Device Identifier: 00803622136245
• UDI-Public: (01)00803622136245(240)627308302(17)230430(10)2110500036
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1