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

Catalog Number 044021301

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

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 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.

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 Description

See initial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ENRICO GRECO; 14401 w 65th way; arvada 80004
• MDR Report Key: 10348855
• MDR Text Key: 203651552
• Report Number: 1718850-2020-00031
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622140303
• UDI-Public: (01)00803622140303(240)44021301(17)220131(10)20006000
• 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: 07/09/2020

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
• Device Operator: 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 Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1