MAUDE Adverse Event Report: SORIN SORIN GROUP DEUTSCHLAND 3T HEATER COOLER; CARDIOPULMONARY BYPASS

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/14/2016

Event Type  malfunction  

Event Description

Discovered our facility used the sorin heater cooler for open heart surgeries.

• Brand Name: SORIN GROUP DEUTSCHLAND 3T HEATER COOLER
• Type of Device: CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN
• MDR Report Key: 6173843
• MDR Text Key: 62376677
• Report Number: MW5066701
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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