PLASMA DONATING MACHINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for PLASMA DONATING MACHINE manufactured by Csl Plasma Inc..

Event Text Entries

[126508211] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081056
MDR Report Key8041978
Date Received2018-11-05
Date of Report2018-11-01
Date of Event2018-05-23
Date Added to Maude2018-11-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePLASMA DONATING MACHINE
Generic NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2018-11-05
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCSL PLASMA INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Deathisabilit 2018-11-05

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