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

Model Number 16S1238416-02-85

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Weakness (2145); Weight Changes (2607)

Event Date 07/27/2015

Event Type  Injury  

Event Description

Original procedure was aortic aneurysm repair.Hospital became aware of patient's infection earlier this month.Patient presented with weight loss and generalized weakness.Blood cultures taken and results have now been identified as m.Avium complex.No final outcome for case, but patient continues to feel poorly and may require additional surgical intervention.The units are the same as previously reported.Manufacturer response for heater cooler unit, stockert heater cooler system 3t (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: 7960646
• MDR Text Key: 123567209
• Report Number: 7960646
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 16S1238416-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25915 DA