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	07/23/2021
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 devices were not available.However, it is the same issue of a previous livanova complaint ((b)(4)) for which the units have been preliminary investigated.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.Device not available.
Event or Problem Description
Livanova usa inc.Has received a report that, during priming, stopcocks were partially occluded.The issue was identified prior to patient involvement.
Additional Manufacturer Narrative
Livanova received a report stating that the stopcocks in pressure monitoring lines were found occluded or partially occluded during priming.There is no report of any patient injury.Investigation on previous similar events confirmed the issue both on complained units and connector still in inventory livanova investigation confirmed effected connectors belong to a single supplier lot.The dhr review confirmed the lot was released conforming to product specification.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 monitoring the market.
Event or Problem Description
See initial report.

• 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: 12267323
• Report Number: 1718850-2021-00042
• Device Sequence Number: 4376753
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1