MAUDE Adverse Event Report: SORING GROUP SORIN HEATER COOLER SYSTEM 3T

Catalog Number 16-02-82

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

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

Pt underwent cardiac surgery cabgx3 on (b)(6) 2015 and developed mediastinal abscess and was taken to surgery on (b)(6) 2016 to remove wires and abscess.Culture done showed m chimaera in chest wound.Pt had the sorin heater device used during cardiac surgery done on (b)(6) 2015 for 92 minutes.

• Brand Name: SORIN HEATER COOLER SYSTEM 3T
• Type of Device: HEATER COOLER SYSTEM 3T
• Manufacturer (Section D): SORING GROUP; lundberg; deutschland; muchen 80939 DE; GM 80939 DE
• MDR Report Key: 6171027
• MDR Text Key: 62275993
• Report Number: MW5066656
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-82
• 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
• Patient Age: 71 YR
• Patient Weight: 122