MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH SORIN 3T; HEATER COOLER UNIT

Model Number 3T

Device Problem Product Quality Problem (1506)

Patient Problem Bacterial Infection (1735)

Event Type  No Answer Provided  

Event Description

Recovery of m.Chimaera from a sorin 3t heater cooler unit.

• Brand Name: SORIN 3T
• Type of Device: HEATER COOLER UNIT
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH ; de
• MDR Report Key: 6379910
• MDR Text Key: 69256208
• Report Number: MW5068256
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3T
• 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