MAUDE Adverse Event Report: LIVANOVA WATER COOLER

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Death (1802); Misdiagnosis (2159)

Event Date 07/03/2015

Event Type  Death  

Event Description

My father died of nontuberculous bacteria which is the subject of fda and cdc health warnings last week.He had aortic heart valve replacement in (b)(6) in july 2014.The doctors here in uk had no clue about this bacteria, so he was incorrectly diagnosed with sarcoidosis and given steroids and methotrexate, which caused his rapid decline between (b)(6) 2016.Is there an organization like the fda that should be sending health warnings to doctors in the(b)(6)? he lived a very healthy lifestyle - lots of sport and healthy eating.

• Brand Name: WATER COOLER
• Type of Device: WATER COOLER
• Manufacturer (Section D): LIVANOVA
• MDR Report Key: 6039447
• MDR Text Key: 57930060
• Report Number: MW5065481
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/17/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 69 YR
• Patient Weight: 65