MAUDE Adverse Event Report: HEATER-COOLER UNIT

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

A (b)(6) y/o with cad s/p cabg in 2008; mv repair on (b)(6) 2016 done at outside hospital (with annuloplasty and gortex valvuloplasty).Now diagnosed disseminated mycobacterium chimaera.Suspected contamination from heater-cooler unit during mv repair in 2016.

• Brand Name: HEATER-COOLER UNIT
• Type of Device: HEATER-COOLER UNIT
• MDR Report Key: 8257067
• MDR Text Key: 133553468
• Report Number: MW5083203
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 85