MAUDE Adverse Event Report: SORIN GROUP SORIN HEATER COOLER

Catalog Number 16-02-82

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fluid Discharge (2686)

Event Date 12/20/2016

Event Type  Injury  

Event Description

Patient had an aortic valve replacement (b)(6) 2014 and developed a large draining mass over chest incision.Wound drainage was positive for mycobacterial chimaera.

• Brand Name: SORIN HEATER COOLER
• Type of Device: SORIN HEATER COOLER
• Manufacturer (Section D): SORIN GROUP; muchen, lindberg 80939 ; GM 80939
• MDR Report Key: 6266210
• MDR Text Key: 65501261
• Report Number: MW5067319
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 16-02-82
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 71