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

Model Number 627299201

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Hemofilter pull pigtail tubing slipping off the leur-lok connector.

• Brand Name: SMART PERFUSION PACK PRESSURE L
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; arvada CO
• MDR Report Key: 16337604
• MDR Text Key: 309298706
• Report Number: MW5114813
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 627299201
• Device Catalogue Number: 27299201
• Device Lot Number: 2225500088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic