MAUDE Adverse Event Report: HEATER-COOLER DEVICE FROM OPEN HEART SURGERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Death (1802); Erythema (1840); Fatigue (1849); Nausea (1970); Vomiting (2144); Weakness (2145); Myalgia (2238); Arthralgia (2355); Weight Changes (2607)

Event Date 06/13/2012

Event Type  Death  

Event Description

"question," open heart surgery will give you 5 to 10 more years with a better quality of life, instead decline in health rapidly.Infections, vomiting, nausea, fatigue, muscle and joint pain, weakness, weight loss, redness and heat never went away a surgery site.I contacted (b)(6) hospital in (b)(6).After receiving a letter about this bacteria.I was told that because my husband had died, nothing could be done and they didn't think even with the problems he had that this was the problem because it is rare.

• Brand Name: HEATER-COOLER DEVICE FROM OPEN HEART SURGERY
• Type of Device: HEATER-COOLER DEVICE FROM OPEN HEART SURGERY
• MDR Report Key: 6328493
• MDR Text Key: 67467162
• Report Number: MW5067850
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ICD; MANY PRESCRIPTIONS
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 139