MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT HEATER-COOLER SYSTEM 1T; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

Model Number 16-02-50

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Burn(s) (1757)

Event Date 10/18/2011

Event Type  Injury  

Event Description

Sorin group (b)(4) received a report that the patient experienced multiple 3rd degree burns while the heater-cooler system 1t was being used as the heat source for a heating blanket.

Manufacturer Narrative

The patient identifier, weight and age were not provided.Sorin group (b)(4) manufactures the stockert heater-cooler system 1t.This device is not distributed in the united states but it is similar to the stockert heater-cooler system 3t which is distributed in the united states.The 510k for the stockert heater-cooler system 3t is k052601.The incident occurred (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group has requested additional information regarding the usage conditions of the device.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: STOCKERT HEATER-COOLER SYSTEM 1T
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3628003
• MDR Text Key: 4177751
• Report Number: 1718850-2014-00009
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1