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

Catalog Number 627380001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypovolemia (2243)

Event Date 06/11/2022

Event Type  Injury  

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 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 Description

See initial report.

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
• Type of Device: 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
• MDR Text Key: 297312409
• Report Number: 1718850-2022-00049
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622135941
• UDI-Public: (01)00803622135941(240)627380001(17)240331(10)2207600054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1