MAUDE Adverse Event Report: HEATER COOLER UNIT CARDIAC BYPASS MACHINE

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.

• Brand Name: HEATER COOLER UNIT CARDIAC BYPASS MACHINE
• Type of Device: HEATER COOLER UNIT CARDIAC BYPASS MACHINE
• MDR Report Key: 7411637
• MDR Text Key: 105379705
• Report Number: MW5076400
• Device Sequence Number: 1
• Product Code: DWC
• 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: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• 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; Disability
• Patient Weight: 86