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

Catalog Number 02016200008

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2020

Event Type  malfunction  

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 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.

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 Description

See initial report.

• Brand Name: NEW COBE CARDIOPLEGIA SYSTEM PACK
• Type of Device: PERFUSION PACK
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada 80004
• MDR Report Key: 10447053
• MDR Text Key: 205481414
• Report Number: 1718850-2020-00035
• Device Sequence Number: 1
• Product Code: DTN
• UDI-Device Identifier: 00803622123702
• UDI-Public: (01)00803622123702(240)02016200008(17)230630(10)020208807
• Combination Product (y/n): N
• PMA/PMN Number: K920312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1