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

Catalog Number	044003901
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Sorin (b)(4) manufactures the cobe smarxt tubing and connectors musc charleston sc1.The incident occurred in (b)(6), united states.The involved device has not been made available for investigation.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova usa inc has received a report that, during priming, the medical team identified that the yellow and white clamps were on reversed lines in cardioplegia set up.There was no patient involvement.
Additional Manufacturer Narrative
The complained circuit was not made available for investigation.However, the customer has provided photographic evidences of the claimed problem.Inspection of the photographic evidences confirmed the cardioplegia line connected to the wye were swapped, this resulted in white and yellow clamp being reversed on cardioplegia line.A review of the dhr did not identify any deviation, non-conformity or material scrap/requests relevant to the reported issue.No other similar complaint was received for the claimed product lot.Livanova investigation confirmed the reported complaint.Livanova believes the most probable root cause is the procedure for circuit assembling that was potentially susceptible to misassembly.To prevent further re-occurrence, the following corrective actions have been implemented: - the relevant manufacturing operating procedure (mop) for circuit assembly has been revised to include a poka-yoke assembly process -manufacturing operator has been trained on the revised procedure.-the print to provided to the manufacturing floor during assembly of this specific circuit pack will be updated to include step by step pictures for the bridge connection of the cardioplegia.Livanova will keep monitoring the market.
Event or Problem Description
See initial.

• 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: 9738125
• Report Number: 1718850-2020-00005
• Device Sequence Number: 1802809
• Product Code: DWE
• UDI-Device Identifier: 00803622113338
• UDI-Public: (01)00803622113338(240)211130(17)044003901(10)1931700012
• 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): 01/29/2020

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: 11/30/2021
• Device Catalogue Number: 044003901
• Device Lot Number: 1931700012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1