MAUDE Adverse Event Report: LIVANOVA USA, INC. SMART PERFUSION PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 627380001

Device Problems Leak/Splash (1354); Defective Component (2292); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/11/2022

Event Type  malfunction  

Event Description

Extracorporeal membrane oxygenation (ecmo) cannula pigtail failed and "popped off" resulting in approx 2 liter blood loss requiring massive transfusion protocol to be activated.Pigtail found to be defective and described as "shredded".Fda safety report id# (b)(4).

• Brand Name: SMART PERFUSION PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 14934869
• MDR Text Key: 295453522
• Report Number: MW5110693
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 627380001
• Device Lot Number: 2207600054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Race: Black Or African American