MAUDE Adverse Event Report: CSL PLASMA INC. PLASMA DONATING MACHINE; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Swelling (2091); Tachycardia (2095); Blurred Vision (2137); Dizziness (2194); Sweating (2444); Palpitations (2467)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I was diagnosed with graves disease 3 years ago and had my thyroid removed a little of two years ago.I was very sick from the graves disease so that's why the removal of my thyroid was necessary.I depend on levothyroxine now everyday of my life, and i take blood pressure medication and have to have my bloodwork done often to see where my tsh levels stand and blood pressure.Anyways, the beginning of (b)(6) this year i was finally feeling better and in fact i believe that i reached the admission stage with graves disease.I felt like "me" again, healthy.I felt so healthy that i began donating my plasma after learning of a new center that previously opened in my area.I had a physical at the center , was honest about my disease and medications, my health history.I was allowed to donate my plasma and did so from the end of may 18 through july 18.So two months i donated my plasma and regularly twice a week.I was offered bonuses at this center for donating my plasma.I felt perfectly fine up until the last visit.The last visit i felt dizzy while hooked up to the machine that separates your proteins.I felt like i was going to pass out and my vein even swelled up a little bit.I was more tired than usual when i returned home.I had my tsh levels checked again around shortly after this time and learned that my levels were completely off.My dr told me that they were so off i was back in the hypothyroidism category and my medication was switched.I felt very sick.I believe this was / is donating my plasma.I'm now in the hyperthyroidism category.I'm sicker than before, my heart is beating irregular, faster.I have more heart palpitations and i feel like a person with m.S.My bones and muscles ache, i feel like vomiting everyday.I feel dizzy at times and tired throughout the day.This has affected me mentally and has interrupted my sleeping schedule.I've been unable to work since my levels changed up and down after donated plasma.My vision has changed along with my monthly cycles.Donating plasma with graves disease is dangerous.I want others to please be aware of this.I could die if i don't continue getting my levels checked and see my dr.I started seeing an endocrinologist from my family dr.I just want to spread awareness.Graves disease pts should not be able to donate the plasma, there has to be another screening process, please, i'm concerned about others.I care.I contacted the center where i donated my plasma about 3-4 weeks ago about this.I want medwatch to know and (b)(4).I'm spreading awareness before someone else with this disease gets hurt like me.

• Brand Name: PLASMA DONATING MACHINE
• Common Device Name: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): CSL PLASMA INC.
• MDR Report Key: 8041978
• Report Number: MW5081056
• Device Sequence Number: 1943239
• Product Code: MMH
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Disability
• Patient Age: 37 YR
• Patient Weight: 69