Systemic inflammatory response syndrome (SIRS) is a potentially deadly condition in which there is inflammation throughout the whole body. One cause of SIRS is exposure to high levels of endotoxins. A recent outbreak of SIRS deaths in patients who had undergone cardiopulmonary bypass (CPG) surgery at a hospital in Virginia was linked by the Centers for Disease Control to a compounding pharmacy, Central Admixture Pharmacy Services, Inc. (CAPS). The CDC determined that contaminated cardioplegia
solution was the most likely cause of the SIRS deaths in the Virginia hospital.
Cardioplegic solution is a solution that is mixed with blood and infused directly into the coronary artery to paralyze the heart during CAB surgery. The Virginia hospital that experienced the cluster of SIRS deaths purchased all of its cardioplegia from CAPS. Obviously, it is absolutely critical that cardioplegia be compounded in a sterile environment and remain sterile at all times. The FDA and Maryland Board of Pharmacy found that the CAPS Maryland facility at which the hospital’s cardioplegia was compounded violated good pharmaceutical manufacturing practices and U.S. Pharmacopecia Chapter 797 sterility guidelines. Moreover, the FDA and CDC found several species of bacteria in intact bags of CAPS cardioplegia and in the areas where the cardioplegia was compounded. As the bacteria that contaminates the cardioplegia dies, it releases from its cell walls endotoxins that can be in amounts sufficient to cause organ death.
On March 15, 2006 the FDA issued to CAP’s parent company, B. Braun Medical, Inc., a warning letter (FDA WARNING LETTER) concerning cardioplegia produced by CAPS at its Maryland and Santa Fe Springs, California facilites, and concerning other infusible products made by CAPS in its Homewood, Alabama, Lanham, Maryland, Horsham, Pennsylvania, and Kansas City, Missouri facilities. On September 16, 2005, CAPS issued an URGENT DRUG RECALL of all of its injectable products manufactured in its Maryland facility. These products had been distributed to hospitals in Maryland, Virginia, the District of Columbia, and Delaware.
If you or a loved one developed SIRS following CAB surgery, and you or the cardiac surgeon suspect that the culprit was endotoxins from contaminated cardioplegia, please contact us through the Ask a Lawyer feature. We are also investigating SIRS cases involving all other injectible products manufactured by CAPS.
Comments for this article are closed.