MAUDE Adverse Event Report: SORIN GROUP USA, INC. STOCKERT HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16S12384

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/13/2012

Event Type  Injury  

Event Description

Patient underwent cardiac surgery four years ago.Now with blood culture results indicating probably (+mac culture).Manufacturer response for heater cooler unit, stockert (per site reporter): none at this time.

• Brand Name: STOCKERT HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 5602948
• MDR Text Key: 43508170
• Report Number: 5602948
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016,04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 16S12384
• Device Catalogue Number: 16-02-85
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR