MAUDE Adverse Event Report: LIVA NOVA (FORMERLY THE SORIN GROUP) SMART PERFUSION PACK (INCLUDES OXYGENATOR/RESEVOIR AND PUMP PACK LINES)

Model Number 044014200

Device Problems Inadequate Instructions for Healthcare Professional (1319); Misconnection (1399); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  Other  

Event Description

The patient was admitted for an avr/mvr/cabg +/- tvr/myectomy.The patient transferred to cvor without incident.While setting up the bypass equipment, the perfusionist inadvertently connected the oxygenator inlet tubing to the outlet adapter and the oxygenator outlet tubing to the inlet adapter.Interchanging these lines was not a concern with the previous equipment model.The new model; however, has a filter that now requires blood to flow in one direction.The equipment has some color coding to assist with set-up, but still permits the tubing to lock with the incorrect adapter.

• Brand Name: SMART PERFUSION PACK (INCLUDES OXYGENATOR/RESEVOIR AND PUMP PACK LINES)
• Type of Device: PERFUSION PACK
• Manufacturer (Section D): LIVA NOVA (FORMERLY THE SORIN GROUP); 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 5273220
• MDR Text Key: 32951980
• Report Number: MW5058361
• Device Sequence Number: 1
• Product Code: DWE
• 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: 12/02/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 044014200
• Device Catalogue Number: 044014200
• Device Lot Number: 3550210142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 79