MAUDE Adverse Event Report: ENRICO GRECO COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	044021301
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.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 obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has been informed that, in two (2) cases, the venous line disconnected from the bcare cuvette while on bypass.Customer reattached the connection and everything worked fine the rest of the case.There is no report of any patient injury.
Additional Manufacturer Narrative
The complained circuit was returned to livanova.A review of the dhr did not identify any deviations, non-conformities, or material scrap/requests relevant to the reported issue.Based on livanova investigation, a potential root cause of the tubing disconnection could be an alteration of the chemical/mechanical characteristics of the tubings.Additionally, the missing tie wrap, not used by the customer, contributed to the reported issue.The risk associated to the event is acceptable.No specific action is deemed necessary livanova will keep 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): ENRICO GRECO; 14401 w 65th way; arvada 80004
• MDR Report Key: 10348855
• Report Number: 1718850-2020-00031
• Device Sequence Number: 2329957
• Product Code: DWE
• UDI-Device Identifier: 00803622140303
• UDI-Public: (01)00803622140303(240)44021301(17)220131(10)20006000
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/09/2020

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: 01/31/2022
• Device Catalogue Number: 044021301
• Device Lot Number: 2000600021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1