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

Catalog Number	044050201
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was identified prior to patient involvement.Livanova usa manufactures the smarxt tubing and connectors.The incident occurred in (b)(6), united stated of america.The involved device has been requested for return.Initial visual inspection and air compressed test of the returned connectors found them to be partially occluded on the male luer leg of the stopcock body or fully occluded in this same location.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 priming, stopcocks were completely blocked or partially occluded.The issue was identified prior to patient involvement.
Additional Manufacturer Narrative
Complained device has been received in livanova and the reported condition has been confirmed.Defect appears to be a possible manufacturing problem.The device is manufactured by a livanova supplier.The supplier has been officially informed of the issue and requested to investigate the problem.Traceability of affected connectors has been completed.The residual risk resulted acceptable.Livanova will maintain monitoring of the market.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova received a report stating that the stopcocks were found occluded or partially occluded when priming the circuit.There is no report of any patient injury.Visual inspection of the connector still in inventory confirmed the issue.Livanova investigation confirmed effected connectors belong to a single supplier lot.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.Based on livanova investigation, the issue is ascribable to a supplier manufacturing problem.As corrective action, the supplier has enhanced the inspection levels and the frequency of sampling.Livanova has also implemented supplier modifications.No other corrective action is deemed necessary.Livanova will maintain the post market surveillance.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Common Device Name: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 12267319
• Report Number: 1718850-2021-00041
• Device Sequence Number: 11856270
• Product Code: DWE
• UDI-Device Identifier: 00803622142123
• UDI-Public: (01)00803622142123(240)044050201(17)044050201(10)2116600053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/14/2021

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: 06/30/2023
• Device Catalogue Number: 044050201
• Device Lot Number: 2116600053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 09/18/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/17/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1