MAUDE Adverse Event Report: SORIN GROUP, LIVA NOVA STOCKERT SORIN GROUP (NOW LIVA NOVA); STOCKERT 3T HEATER-COOLER

Model Number 3T

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Type  malfunction  

Event Description

Despite strict compliance with manufacturer recommendations for cleaning, the sorin heater-cooler unit used during the performance of open heart surgery tested positive during routine culturing of equipment for (b)(6).This may have exposed the pts to a potential source of infection.

• Brand Name: SORIN GROUP (NOW LIVA NOVA)
• Type of Device: STOCKERT 3T HEATER-COOLER
• Manufacturer (Section D): SORIN GROUP, LIVA NOVA STOCKERT; linderghstrasse 25; munchen 80939 ; GM 80939
• MDR Report Key: 5725533
• MDR Text Key: 47424211
• Report Number: MW5062864
• Device Sequence Number: 1
• Product Code: DWC
• 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

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: 3T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other