MAUDE Adverse Event Report: WATER COOLER UNIT FOR CARDIAC SURGERY; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/12/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 my father was finally diagnosed with mycobacterium chimaera infection after 1.5 years of progressive symptoms.He underwent an aortic valve replacement surgery on (b)(6) 2015 at (b)(6).Doctors failed to diagnose this infection despite knowing of an exposure to this life threatening bacteria from contaminated operating room equipment.Because of the delay in diagnosis, the infection is now disseminated with brain involvement, leaving my father debilitated and in life-threatening condition.It is imperative that this information serve as a warning to countless other patients at risk of death before it is too late to effectively treat, or worse have already died because of misdiagnosis.Fda safety report id# (b)(4).

• Brand Name: WATER COOLER UNIT FOR CARDIAC SURGERY
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• MDR Report Key: 12779308
• MDR Text Key: 280581322
• Report Number: MW5105170
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2021

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White