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

Catalog Number	044003907
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack musc (b)(4).The incident occurred in (b)(4), united states.The involved device is not available for investigation.However, photographic evidences showing the reported issue were provided by the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova inc has received a report that, during set up, it was discovered the yellow and white clamps were reversed on del nido cardioplegia tubing.There issue was identified prior to any patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The complained circuit was not made available for investigation.The customer has provided picture that showed the reported misassembly: the issue has been confirmed based on the inspection of the provided pictures.A review of the dhr identified no deviations, non-conformity or material scrap/requests relevant to the reported issue was identified.Analysis of the livanova complaint database found five other events of cardioplegia circuits misassembly all related to other item circuits.No further similar complaint was received for the claimed item circuit in the last 12 months.Livanova investigation suggests the most probable root cause of the misassembly was an operator error occurred during the manual assembly steps.The issue was also not detected during the subsequent visual inspection performed at the end of the manufacturing.To prevent further occurrence of this issue, manufacturing operators has been retrained.The risk is acceptable.No other corrective action is deemed necessary.Livanova will keep monitoring the market.Device not available.

• 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: 10384911
• Report Number: 1718850-2020-00032
• Device Sequence Number: 13884541
• Product Code: DWE
• UDI-Device Identifier: 00803622144882
• UDI-Public: (01)00803622144882(240)044003907(17)220131(10)2007100030
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 044003907
• Device Lot Number: 2007100030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1