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

Catalog Number 044042601

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Livanova usa inc manufactures the convenience pack rochester gen rchstr ny 1.The incident occurred in (b)(6).The involved device has not been requested for return to livanova usa inc 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 Description

Livanova inc has received a report that, during a procedure, it was discovered that the cardioplegia delivery set in the pack was misassembled potentially leading to the delivery of an incorrect ratio of blood/cardioplegia solution.There is no report of any patient injury.

Manufacturer Narrative

The customer has provided pictures that showed the reported misassembly: the issue has been confirmed based on the inspection of the provided pictures.As the pictures were evaluated adequate to assess the issue, the complained circuit was not requested for investigation.A review of the dhr identified that the form aimed to record the final correct assembly of the circuit had not been included in the dhr.No other deviations, non-conformities 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.To prevent further occurrence of this issue, manufacturing operators has been retrained.An internal non conformity has been opened to investigate the cause for the absence of the form aimed to record the final correct assembly.The risk is acceptable.No other corrective action is deemed necessary.Livanova will keep monitoring the market.H3 other text : device not necessary.

Event Description

See initial report.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10313031
• MDR Text Key: 203382885
• Report Number: 1718850-2020-00028
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622137242
• UDI-Public: (01)00803622137242(240)044042601(17)220331(10)2006400034
• Combination Product (y/n): N
• PMA/PMN Number: K981613
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 044042601
• Device Lot Number: 2006400034
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1