MAUDE Adverse Event Report: SORIN GROUP HEATER COOLER SYSTEM 3T

Catalog Number 16-02-82

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Unspecified Infection (1930)

Event Date 11/23/2016

Event Type  Injury  

Event Description

This patient had open heart surgery (b)(4) (b)(6) 2014.Patient developed sternal drainage around (b)(6) 2016 and was brought in for surgery.Patient had surgery (b)(6) 2016.The findings were sternal wound fistula tracked down to the most inferior sternal wire and a pus pocket around the second most inferior sternal wire.Both wires were removed.Bacterial culture were negative but afb culture showed mycobacterium chimaera.

• Brand Name: HEATER COOLER SYSTEM 3T
• Type of Device: HEATER COOLER SYSTEM 3T
• Manufacturer (Section D): SORIN GROUP; muchen, lindberg 80939 DE; GM 80939DE
• MDR Report Key: 6185122
• MDR Text Key: 62836295
• Report Number: MW5066740
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-82
• Was Device Available for Evaluation?: Yes
• 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
• Treatment: CARDIAC SURGERY FOR 137 MINUTES. ; PATIENT HAS SORIN HEATER COOLER USED DURING
• Patient Outcome(s): Hospitalization
• Patient Weight: 58