HOUSTON (CN) – Parents say their baby died because the Triad Group’s alcohol wipes were contaminated with cereus bacteria. A doctor used the wipes to sterilize their 2-year-old son’s lumbar drain, and the resulting infection killed him in 3 days, the parents claim in Federal Court. The product was recalled a month later.
A month after the boy died of multi-organ failure, Triad recalled “‘all lots’ of its ‘alcohol prep pads, alcohol swabs, and alcohol swabsticks’ due to the contamination of the products ‘with an objectionable organism,'” Sandra and Shanoop Kothari say in their complaint.
Two days later, the U.S. Food and Drug Administration also announced a recall of Triad’s products. “The recall was initiated because Triad’s alcohol prep products were potentially contaminated with bacillus cereus,” according to the complaint, which describes bacillus cereus as “a potentially life threatening bacteria that is normally associated with food-borne illnesses.”
Their son, HK, underwent a left frontotemporal craniotomy on Sept. 20, 2010, and doctors made an incision in his head to drain an arachnoid cyst, according to the complaint.
For 2 months cerebrospinal fluid leaked from HK’s incision, a “known risk” for infections, and his parents took him back to the hospital to have a lumbar drain placed in his back to drain the fluid, the parents say.
“The lumbar drain was replaced on November 22, 2010. Multiple specimens were
cultured at that time, the results of which showed no sign of infection,” the complaint states. “HK continued to do well, with normal activities, no neurologic symptoms and no fever.”
Then cerebrospinal fluid was drawn from HK’s lumbar drain for culture, the Kotharis say. “This process involved sterilizing the area around the lumbar drain using alcohol wipes, pads and/or swabs. The alcohol wipes, pads and/or swabs used during HK’s treatment for the cleaning and sterilizing of the lumbar drain were manufactured by Triad,” according to the complaint.
HK made steady improvement, but hours before he was scheduled to be discharged, on Nov. 29, 2010, he began vomiting and having seizures, the Kotharis say. He stopped breathing while undergoing a CT scan.
Subsequent cultures of HK’s spinal fluid and blood tested positive for bacillus cereus. “Bacillus cereus is rarely found in hospital-acquired infections,” the complaint states. “HK was declared dead at 12:54 p.m. on December 1, 2010 at the age of 2,” his parents say. “The cause of HK’s death was determined to be acute bacterial meningitis with septicemic syndrome of bacillus cereus, leading to multi-organ failure.”
Triad issued its recall on Jan. 3.
The Kotharis sued only the Triad Group, seeking damages for product liability, negligence and wrongful death.
They are represented by Houston attorney Jim Perdue.