MAUDE Adverse Event Report: SORIN STOCKERT HEATER-COOLER SYSTEM 3T

Lot Number PART #16-02-82

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/02/2016

Event Type  malfunction  

Event Description

Sorin 3t machine grew out a mai from the water taken from the patient side port of the machine.Dates of use: (b)(6) 2013 - (b)(6) 2016.Reason for use: bypass surgery.

• Brand Name: STOCKERT HEATER-COOLER SYSTEM 3T
• Type of Device: STOCKERT HEATER-COOLER SYSTEM 3T
• Manufacturer (Section D): SORIN; milan ; IT
• MDR Report Key: 5586817
• MDR Text Key: 43029934
• Report Number: MW5061763
• 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
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Lot Number: PART #16-02-82
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other