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

Catalog Number	627380001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Sorin group (b)(4) manufactures the smart perfusion pack.The incident occurred in (b)(6), united states of america.The complained connector is available.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
On july 12, 2022, livanova received the medwatch mw5110693 stating ¿extracorporeal membrane oxygenation (ecmo) cannula pigtail failed and "popped off" resulting in approximately 2 liter blood loss requiring massive transfusion protocol to be activated.Pigtail found to be defective and described as "shredded".
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Based on follow up with livanova sale manager, it was clarified that the present medwatch 1718850-2022-00049 and medwatch 1718850-2022-00043 reports refer to the same event.The livanova complaint (b)(4) (corresponding to the medwatch 1718850-2022-00043) was submitted by the livanova personal following the meeting with the ecmo director at abington the livanova complaint (b)(4) (corresponding to the present report, medwatch 1718850-2022-00049) was submitted following receiving by email the medwatch mw5110693 on july 12, 2022.As for the above, a follow up the present medwatch report is being submitted and the livanova complaint (b)(4) will be voided.Result of the event evaluation have already been submitted as follow up of medwatch 1718850-2022-00043.

• 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
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15173624
• Report Number: 1718850-2022-00049
• Device Sequence Number: 5021378
• Product Code: DWE
• UDI-Device Identifier: 00803622135941
• UDI-Public: (01)00803622135941(240)627380001(17)240331(10)2207600054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 627380001
• Device Lot Number: 2207600054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown