* Companies report cases of sparking, fires - FDA
* Cords made by Electri-Cord Manufacturing - FDA
* Risks include electrical shock, death - FDA
(Adds Abbott comments)
By Lisa Richwine
WASHINGTON, Oct 19 (Reuters) - U.S. regulators are
investigating whether certain power cords used with medical
devices may be defective after two companies reported fires
from the cords, the Food and Drug Administration said on
Monday.
Hospira Inc (HSP.N) and Abbott Nutrition have sent the FDA
122 reports of sparking, charring and fires from power cords
used with their devices, the agency said. Abbott Nutrition is a
unit of Abbott Laboratories Inc (ABT.N).
All of the reports received so far have involved AC power
cords with a black plastic bridge manufactured by Electri-Cord
Manufacturing Co, the FDA said.
The agency said Electri-Cord supplied the affected power
cords to other device makers and the FDA was trying to
determine which products were equipped with the cords.
Investigations by Abbott and Hospira found the power cord
prongs may crack and fail at or inside the plug, the FDA said.
Potential risks from power cord failure include electrical
shock and device failure, the FDA said.
"Depending on the device and therapy, these failures may
potentially lead to serious adverse health consequences,
including death," the agency said.
Dennis McDonald, general manager for Electri-Cord, said the
company had received only 26 reports of failures of cords with
the black plastic bridge out of about 2 million the company has
shipped.
Cords examined after the incidents "show signs of
significant abuse in their use environment ... it's not a
manufacturing defect," McDonald said in an interview.
Hospira announced in August that it was voluntarily
recalling certain power cords used with some of the company's
infusion pumps and related products. The FDA sent a letter to
Hospira that same month warning the company about the way it
responded to problems reported with power cords.
Abbott spokesman Scott Stoffel said on Monday the recall
affected the company's Flexiflo Quantum pumps used for adult
feeding tubes in hospitals and that Abbott is working with
customers to fix or replace the devices.
"We've received no reports of serious health or safety
incidents," he said.
Officials at Hospira did not respond to requests for
comment.
The FDA urged all users of medical devices to monitor
closely the wear and tear on the electrical cords used to power
the devices. Monitoring is "especially important in oxygen-rich
environments, in which electrical sparking and arcing may
trigger a fire," the agency said.
The FDA statement was posted here.
(Reporting by Lisa Richwine, editing by Richard Chang, Matthew
Lewis and Andre Grenon)
