MAUDE Adverse Event Report: HEATER COOLER

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

Patient Problems Stacking Breaths (1593); Death (1802); Fatigue (1849); Fever (1858); Pain (1994); Pleural Effusion (2010); Weakness (2145); Weight Changes (2607)

Event Type  Death  

Event Description

After my husband (b)(6) had a tavert surgery he started going downhill.He had this one done in 2013.Some symptoms he had was shortness of breath, which led to having to be on oxygen.He had weakness felt, feverish, a lot muscle aches.There was no family history of problems.He had none until sometime after this operation.He had thickening in his lungs like a jell.They didn't know why pleural infusions.Went to doctor after doctor and these were specialist who had no answers.He also had fatigue and lost a lot of weight and the list goes on.He was also in and out of hospitals.Sad to say he died (b)(6) 2016.What really upsetting is in (b)(6) 2016 i got letter from (b)(6) hospital informing me that the fda is investigating the heater device that was used in those kind of surgeries.What's sad is that if (b)(6) hospital would of let us known when they first heard or was informed in 2015 about 4 devices being recalled.Maybe my husband would still be alive today because we could of had him tested for this bacteria which we feel may of been even growing around his heart then he could of have medicine and even a new valve put in so in my opinion tampa general could have some blame in this too for not informing their patients in a timely manner.My family and i also feel there was neglect on some doctors which we can prove, but at this time not go.So in closing, i lost my husband of 62 years, and my children lost their father.The world lost a good man.

• Brand Name: HEATER COOLER
• Type of Device: HEATER COOLER
• MDR Report Key: 6328491
• MDR Text Key: 67467872
• Report Number: MW5067849
• Device Sequence Number: 1
• Product Code: DWC
• 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: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 81 YR