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

Catalog Number	627336403
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Sorin group italia manufactures the smart perfusion pack.The incident occurred in (b)(6).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova usa received a report that during installation of the circuit, the tubing disconnected from the connector even when its tie banded.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that during priming the tubing just slipped back off the 3/8 connector even when it was tie banded.Picture of the issue was received, confirming it.Pack was not available for return.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.By reviewing the complaints database, a further similar event for tubing disconnection related to this connector has been recorded on the same pts pack code, but different lot number.This involved 3/8 connector is assembled with the tubing through the use of solvent and then tie banded.Based on above and without sample to analyze, it cannot be ruled out that the disconnection was due to the following possible root causes: - insufficient presence of solvent, - tie band not tight enough, - tubing and/or connector dimensional issue.The risk is in the acceptable region.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14955288
• Report Number: 1718850-2022-00042
• Device Sequence Number: 20556936
• Product Code: DWE
• UDI-Device Identifier: 00803622133374
• UDI-Public: (01)00803622133374(240)627336403(17)231031(10)2128400044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 10/31/2023
• Device Catalogue Number: 627336403
• Device Lot Number: 2128400044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown