MAUDE Adverse Event Report: LIVA NOVA SORIN / LIVA NOVA USA, INC. LIVA NOVA SORIN 6F INSPIRE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number REF # 044003200

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 08/08/2019

Event Type  Injury  

Event Description

Fluid was seen leaking out of the sorin inspire 6f oxygenator temperature port during priming.It was changed out and reported to the company.Thankfully it was noticed before cpb was initiated.Recently, among a discussion with colleagues this is a common serious problem (12+ cases at least) and blood leaks out of the port during the cpb run and a serious sterility and cross contamination issue as the temp probe is reused and put into the temperature prob port with the leak.Fda safety report id # (b)(4).

• Brand Name: LIVA NOVA SORIN 6F INSPIRE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVA NOVA SORIN / LIVA NOVA USA, INC.
• MDR Report Key: 9805331
• MDR Text Key: 182922312
• Report Number: MW5093618
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF # 044003200
• Device Lot Number: 1912700021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention