SEE BLOOD BANK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-02 for SEE BLOOD BANK manufactured by See Blood Bank.

Event Text Entries

[827823] Date field above is not relative, please excuse it. This is not a complaint of cause of damage, only a statement of possible caution and relationship between two events that could lead to greater understanding of meniere's disease. I started giving blood at the blood bank in the 2007. At first they just drew blood, but later i was asked if i would donate platelets. The bba uses acda - anticoagulant citrate dextrose solution, formula a, in their centrifuge machine. I have participated in four sessions of this and coinciding with those sessions i notice pressure build up in the inner ear and sensitivity to noise, in my right ear. I passed this off as a simple sinus infect that perhaps was coming back due to a mildly weakened immune system. I do state that there was no fluids, or runny nose during this irritation period. I would not go back right away because i wanted to make sure there was no infecton that could be passed on. The time periods between my going back in to give blood increased due to experiencing these effects. I have been diagnosed now with meniere's disease and i have lost already about 60% hearing from that ear. The bba has on file my comment about my coincidental timing of these symptoms and my having blood drawn. There is no way i can state my sensitivity to this process relative to anyone else. I can tell you that i felt lost of concentration, fuzzy thinking, buzzing of the lips with the nature of the calcium binder that acda effects influence. I did eat lots of tums to counter act these effects. There may be a link, association, chain reaction with acda an the onset of the symptoms of meniere's disease. Potassium, sodium, calcium are all salts. The fluids in the inner ear are potassium based and are carefully regulated in the cochlea. The loss ability to regulate the fluid pressure inside the inner ear is a symptom of meniere's disease and is the one that causes the permanent hearing loss, and attacks of the world spinning around for 6 hrs at a time. Please note, this comment, and possible consideration of relevance as a matter of record. It may later be important to understand more about meniere's disease, or mount growing concern of the possible effects of acda.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006113
MDR Report Key1025013
Date Received2008-04-02
Date of Report2008-04-02
Date of Event2007-08-01
Date Added to Maude2008-04-14
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 Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSEE BLOOD BANK
Generic NamePLATELETS CENTRIFUGE MACHINE
Product CodeKSO
Date Received2008-04-02
Model NumberSEE BLOOD BANK
Catalog NumberSEE BLOOD BANK
Lot NumberSEE BLOOD BANK
ID Number*
OperatorOTHER
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key993474
ManufacturerSEE BLOOD BANK
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2008-04-02

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