Human Error Was Blame For Deaths. Human error, and not a medical device, was to blame for the deaths of two patients at the Hospital of St. Raphael, the U.S. Food and Drug Administration said Tuesday in a preliminary decision.
The FDA said that the device – a meter that regulates oxygen flow – was erroneously connected to a nitrous oxide outlet instead of an oxygen outlet.
The mistake resulted in the deaths of two women who inhaled fatal doses of the anesthetic instead of oxygen during heart procedures.
The FDA also found that dim lights in a procedure lab and a missing positioning pin on the oxygen flow meter were factors in the deaths.
“We have no evidence the device itself failed,” FDA spokeswoman Sharon Snider said. The FDA believes human error also led to the positioning pin being broken off the device.
“It did have a pin missing, but we don’t have any insight as to how that happened. There was no evidence of tampering,” Snider said.
The FDA, which regulates medical devices, is continuing to investigate.
A final ruling from the FDA is expected later this year. The agency did not issue a written report Tuesday.
Doris Herdman, 72, of Southington, and Joan Cannon, 68, of Wallingford, died in January when they were accidentally given the nitrous oxide during a heart procedure.
Staff Could Not See The Color Coding
Gas meters and wall outlets are color-coded and have positioning pins to prevent gas mix-ups. But because of the dim lights, hospital staff could not see the color-coding, the report said.
Oxygen meters have positioning pins at 12 o’clock and 6 o’clock, while the nitrous oxide meter’s pins are at 12 o’clock and 7 o’clock. These pins make it impossible for the meter to be plugged into the wrong gas outlets unless one of the pins is missing.
Hospital spokeswoman Cindy von Beren said the FDA has not contacted hospital leaders about its preliminary findings.
“Until we have some word from them, preliminary or otherwise, we really can’t comment,” von Beren said.
Officials from the device manufacturer, Precision Medical Inc. of Northampton, Pa., could not be reached for comment. Messages were left at their office.
A state Department of Public Health report, issued last week, also said that the lighting in the cardiac catheterization room was dim. The gas outlets were hard to see, and hospital staff said they had to get on their hands and knees to reach the outlets.
Hospital officials are scheduled to meet with state investigators today to review the state report. The state will then issue a final ruling and announce any disciplinary action against St. Raphael’s.
The hospital has said it has corrected other problems identified by the state. The nitrous oxide has been disconnected from the cardiac catheterization rooms.