April 12, 2000
Warning to Hospitals and Hemodialysis Units - TriCitrasol May Cause Death
Washington, DC (SafetyAlerts) - The Food and Drug
Administration is issuing an urgent warning to all 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 after 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 dilution.
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.