MAUDE Adverse Event Report: SORIN SORIN; HEATER COOLER DEVICE

Model Number 3T

Device Problems Contamination (1120); Product Quality Problem (1506)

Patient Problem Unspecified Infection (1930)

Event Date 09/30/2016

Event Type  Injury  

Event Description

M.Chimaera isolated from wound culture from pt after left ventricular assist device (lvad) on (b)(6) 2016.Lvad placed on (b)(6) 2015, 3t heater cooler device used during surgery.

• Brand Name: SORIN
• Type of Device: HEATER COOLER DEVICE
• Manufacturer (Section D): SORIN ; de
• MDR Report Key: 6099531
• MDR Text Key: 59786958
• Report Number: MW5066012
• 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: Physician
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3T
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR