US Food and Drug Administration
Warning on tricitrasol dialysis catheter anticoagulant
FDA Talk Paper
(Apr) 16:4-14-2000, 2000
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel
in responding with consistency and accuracy to questions from the public on
subjects of current interest. Talk Papers are subject to change as more
information becomes available.
T00-16 Print Media:
April 14, 2000 Broadcast Media:
FDA ISSUES WARNING ON TRICITRASOL
DIALYSIS CATHETER ANTICOAGULANT
The Food and Drug Administration is issuing an urgent warning to
hospital pharmacies and hemodialysis units that triCitrasol, an unapproved
product that has been used to keep bloodlines open, may cause death when
infused into patients. TriCitrasol is marketed in individual, sterile, 30ml
glass vials, distributed both individually and in hemodialysis kits.
FDA has learned that a patient died of cardiac arrest shortly
triCitrasol, a 46.7% concentration of sodium citrate anticoagulant, was
injected full strength into a hemodialysis permanent blood access catheter
that had just been implanted. Rapid or excessive infusion of citrate
solutions can cause fatal heart rhythm disruption, seizures or bleeding due
to loss of blood calcium.
Other incidents that may involve triCitrasol in the hemodialysis
setting are under FDA review.
TriCitrasol is manufactured by Cytosol Laboratories, Braintree,
Mass., and is distributed by Medcomp, Harleysville, Pa., and previously by
Citra Anticoagulants, Inc. Both Cytosol Labs and Medcomp are voluntarily
recalling triCitrasol for use with blood access catheters.
FDA is urging hospital pharmacies and hemodialysis units across
the U.S. to stop using the product. Alternative 4% solutions of citrate are
available for use in these and most other medical settings.
Because there is a need for this product in some procedures to
prepare white cells for transfusion, FDA is working with the company to see
that the product currently remains available for this use, which involves
In an April 9, 2000 letter to its customers, Medcomp announced a
recall of its kits (or trays) containing triCitrasol and the Medcomp Ash
Split Catheter II, for hemodialysis or apheresis, a blood separation and
re-transfusion process. Approximately 3000 Medcomp catheter kits
with triCitrasol were distributed nationwide. They were also distributed to
Puerto Rico and Canada.
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