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

Model Number 627299201

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

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

• Brand Name: SMART PERFUSION PACK PRESSURE LINE
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; arvada CO
• MDR Report Key: 16304494
• MDR Text Key: 308928839
• Report Number: MW5114685
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic