MAUDE Adverse Event Report: SORIN GROUP SORIN 3T HEATER COOLER UNIT

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Fever (1858); Hepatitis (1897); Pneumonia (2011)

Event Date 12/12/2015

Event Type  Injury  

Event Description

Patient with history of rheumatic heart disease who had a mitral valve repair and annuloplasty in (b)(6) 2014, presented in (b)(6) 2015 with 3 weeks of fevers of unknown origin. Found to have nonviral (b)(6), developed pneumonia in hospital, found to have new vegetation on prosthetic mitral valve ring. Taken to operating room for valve replacement, and valve tissue had (b)(6). Tissue cultures subsequently grew mac/m. Chimaera. Sorin 3t heater cooler unit was used during patient's bypass for mitral valve reconstruction and annuloplasty on (b)(6) 2014.

• Brand Name: SORIN 3T HEATER COOLER UNIT
• Type of Device: SORIN 3T HEATER COOLER UNIT
• Manufacturer (Section D): SORIN GROUP; IT
• MDR Report Key: 5419455
• Report Number: MW5060052
• 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: Physician
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 28 YR
• Patient Weight: 60
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention