MAUDE Adverse Event Report: LIVANOVA USA INC NEW COBE CARDIOPLEGIA SYSTEM PACK; PERFUSION PACK

Catalog Number	02016200008
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack childrens hsp boston ma 1.The incident occurred in boston, massachusetts, united states.The involved device is not available for investigation.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 priming, it was noticed that the cardioplegia set was misassembled and the direction of flow through the cardioplegia circuit table lines was incorrect.The issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
The complained circuit was not made available for investigation.The issue has been confirmed based on event description.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 no other similar complaint received for the claimed item circuit in the last 12 months.Livanova investigation suggests the most probable root cause of the misassembly was an isolated 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.
Event or Problem Description
See initial report.

• Brand Name: NEW COBE CARDIOPLEGIA SYSTEM PACK
• Common Device Name: PERFUSION PACK
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada 80004
• MDR Report Key: 10447053
• Report Number: 1718850-2020-00035
• Device Sequence Number: 19471094
• Product Code: DTN
• UDI-Device Identifier: 00803622123702
• UDI-Public: (01)00803622123702(240)02016200008(17)230630(10)020208807
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K920312
• 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): 11/09/2020

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: 02016200008
• Device Lot Number: 020208807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1