LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|