[239478]
In 02/2002 a therakos sales rep was at facility where he learned that a pt became hypotensive and fainted. This occurred on a previous date. Therakos called to follow-up on this report as it had not previously been reported to therakos. A cutaneous t-cell lymphoma pt with triglyceride levels around 800-900, most likely side effects of targretin the pt was receiving, had a hypotensive episode and fainted. Currently it is believed that because of the opaque color of the hyperlipidemia plasma, the centrifuge bowl optics on the uvar xts instrument may have activated early upon seeing the opaque plasma vs. The plasma/red blood cells interface. This early trigger by the bowl optic sensor can cause increased extracorporeal volume. However, there are alarms in place to warn the operator. After speaking with the nursing staff at facility, it was learned that the co's instrument did produce a "buffy coat volume exceeded" alarm. This alarm is produced when the instrument senses it has collected 150mls of plasma and buffy coat. This alarm is a warning to evaluate the pt for any signs of hypotension. This alarm is resettable three times. Each time it is reset, it permits the instrument to collect an additional 30 mls of plasma/buffy coat. If the operator resets the alarm three times, the alarm is not resettable regardless of the ability of the pt to tolerate the extracorporeal volume. The co learned in the co's discussion with the nurse that the necessary instrument alarms did occur and the "buffy coat volume exceeded" alarm was reset twice prior to the 110- pound pt fainting from hypotension. This pt was treated the day before this event without incident. Tne nurse performing the treatment on that day was aware that due to the pt's small size, pt selcted to perform only four of the six treatment cycles. The pt required medical intervention to alleviate the hypotension episode (additional fluids given). The pt did not require an adiditonal hosp stay as a result of this event. Facility, in a letter to therakos dates 2/2002, indicates that a second pt with triglyceride levels above 500 resulted in a risk of excessive extracorporeal blood levels which did not proceed to a hypotension episode. Therakos is aware of a new drug on the market in the treatment of ctcl known as targretin. The drug appears to cause significant rise in triglyceride levels in many pts using the drug. This causes pt's plasma to turn opaque or milky. If this condition is not adequately controlled by dietary or cholesterol lowing medications, it could affect the optical sensors in the uvar xts instrument as well as have an affect on the cardiovascular system in pts.
Patient Sequence No: 1, Text Type: D, B5