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

Catalog Number 627380001

Device Problem Disconnection (1171)

Patient Problems Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group italia manufactures the smart perfusion pack.The incident occurred united states of america.The complained connector is available and has not been requested.During follow up with the customer, livanova was informed that the patient received four units of packed red blood cells, three units of fresh frozen plasma, and two units of platelets.According to the intensivist, there is no report of any patient injury.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device available and not requested.

Event Description

Livanova usa received a report that after 15 days ecmo support, the connector hooked up to a distal perfusion catheter (male end attaches to an arterial cannula and the stopcock portion attaches to a distal perfusion catheter) disconnected.Patient lost approximately one liter of blood.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a report stating that during support in ecmo, customer noticed that a pigtail connector fell apart while it was hooked up to a distal perfusion catheter picture and video of the issue were received, confirming it.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.By reviewing the complaints database, further similar events for tubing disconnection related to this pigtail connector have been recorded on the same pts pack code, but different lot number, always used in ecmo.This involved pigtail connector is assembled with the tubing through the use of solvent.As per ifu indications, this pts pack is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, not for ecmo.Based on above, it cannot be ruled out that the reported event was due to the prolonged use (15 days) in ecmo, while this product is validated for maximum 6 hours of use.The risk is in the acceptable region.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): 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: 14955283
• MDR Text Key: 295476700
• Report Number: 1718850-2022-00043
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 627380001
• Device Lot Number: 2207600054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• 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