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

Catalog Number	627338801
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack inspire 8fs cardioflex.The incident occurred in (b)(6) united states united states.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 unpacking, one of the luer in the cardioplegia lines was incorrectly assembled so that it would not be possible to switch out the connection and change the ratio of the cardioplegia.There issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
Livanova received a report that the male luer in the cardioplegia line was incorrectly assembled so that it would not be possible to switch out the connection and change the ratio of the cardioplegia.There issue was identified during unpacking prior to any patient involvement.At the submission of the case, customer has provided photographic evidence of the misassembly.The dhr review confirmed the complained lot was released conforming to product specifications.No other unit of the lot was complained for similar issue so livanova believes this is an isolated event.Based on above and previous internal investigation, the most probable root cause is an operator error during the manual assembly: the male/female luers were twisted before attaching them to the tubing and turned upside down.As part of internal procedure, manufacturing personnel was re-trained on the assembly schemes on (b)(6) 2021.Complained unit was manufactured before the re-training done on may.Therefore, no additional re-training was planned and no other corrective action was deemed necessary.Livanova will maintain 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
• MDR Report Key: 11981666
• Report Number: 1718850-2021-00033
• Device Sequence Number: 19914019
• Product Code: DWE
• UDI-Device Identifier: 00803622124587
• UDI-Public: (01)00803622124587(240)627338801(17)230331(10)2108200105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 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: No Information
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 627338801
• Device Lot Number: 2108200105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 09/19/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1