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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEATER COOLER UNIT CARDIAC BYPASS MACHINE

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HEATER COOLER UNIT CARDIAC BYPASS MACHINE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Misdiagnosis (2159)
Event Type  Injury  
Event Description

Mitral valve replacement and double cabg on (b)(6) 2017 at (b)(6) hospital, (b)(6). Had r foot pain within one month of surgery, developed redness on foot over the next 6 weeks or so, sent to wound care when abscess developed, continued to have abscesses erupt on foot. X-ray revealed osteomyelitis and bone fx unknown etiology. Now we know the infection caused fx. Which she has 2 fx, 1st metatarsal at site of wound and calcaneus at the site of first pain. Has been on multiple antibiotics, required 3 hospitalizations and an extended care stay with harmful antibiotics. Had r hand develop abscess and erupt while on vancomycin and other medications. No improvement and multiple misdiagnosis. Review of literature by family and dermatologist for 2nd opinion revealed possible heater cooler mycobacterium contamination, mri done revealing extensive bone infection taken to university of south alabama medical center where we are still currently. Tissue bx revealed mycobacterium under scope, pet scan revealed inflammation/ infection in sternal area although heart valves clear at this time per tests. Awaiting mycobacterium growth/ identification/ susceptibility. We need assist to identify this bacteria before patient declines further.

 
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Brand NameHEATER COOLER UNIT CARDIAC BYPASS MACHINE
Type of DeviceHEATER COOLER UNIT CARDIAC BYPASS MACHINE
MDR Report Key7411637
MDR Text Key105379705
Report NumberMW5076400
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/09/2018 Patient Sequence Number: 1
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