MAUDE Adverse Event Report: LIVANOVA (FORMERLY SORIN GROUP S.P.A.) SORIN 3T PERFUSION HEATER-COOLER; THERMAL REGULATOR DEVICE

Model Number 3T

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Sorin 3t perfusion heater-cooler tested positive for (b)(6).Hospital has not identified any ntm infections in patients.The device has been sequestered and disinfected pursuant to manufacturer recommendations and continues to receive recommended activities at recommended intervals.Microbiological sampling is being done continuously and passing results are pending.Device failed water sampling testing on (b)(6) 2015.Same reporter as mw5060140, mw5060141, mw5060142, mw5060144, mw5060145.

• Brand Name: SORIN 3T PERFUSION HEATER-COOLER
• Type of Device: THERMAL REGULATOR DEVICE
• Manufacturer (Section D): LIVANOVA (FORMERLY SORIN GROUP S.P.A.); via benigono crespi, 17; milano 20159 ; IT 20159
• MDR Report Key: 5433976
• MDR Text Key: 38239130
• Report Number: MW5060143
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3T
• Device Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other