MAUDE Adverse Event Report: LIVANOVA/SORIN 3T HEATER COOLER MACHINE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Contamination (1120)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 03/03/2017

Event Type  Injury  

Event Description

Pt had cabg x 4 on (b)(6) 2016 and came back on (b)(6) 2017 with wound dehiscence.Sorin 3t heater cooler device (livanova) utilized during surgery.Pt confirmed positive for m chimaera on results received from (b)(6) lab on (b)(6) 2017.Machine returned to livanova.Case reported to livanova as well.Pt being treated by infectious disease as outpatient for wound infection.Wound is superficial and according to id did not involve the bone.

• Brand Name: 3T HEATER COOLER MACHINE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA/SORIN; munich, de
• MDR Report Key: 6646676
• MDR Text Key: 77837853
• Report Number: MW5070434
• 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: 06/14/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 62