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1993.11.23 :  $290,000 Fine for Infusaid

Food and Drug Administration
Sharon Snider (301) 443-3285
Nov. 23, 1993

The FDA today announced that the manufacturer of an implantable
infusion pump, used to give patients drugs, has agreed to pay a
$290,000 tine for marketing an unapproved medical device.

The civil money penalty against Infusaid Inc. of Norwood,, Mass.,
a division of Pfizer Hospital Products Group, is the first
imposed by FDA under the Safe Medical Devices Act of 1990.

Infusaid was cited for distributing a drug pump to which it had
made significant changes without FDA approval. Infusaid's altered
pump--a nodal 400--leaked, potentially endangering health by
delivering too much drug to Some Patients.  The firm received 10
complaints of product failure or patient injury.

In addition, the firm was cited for failing to manufacture the
device in accordance with Good Manufacturing Practice regulations
because the pumps failed to meet the firm's specifications.  Both
problems were uncovered during FDA inspections of the firm.

Infusaid agreed to pay the fine without admitting liability,
wrongdoing or illegal conduct.

"FDA regulations are intended to protect the public health and we
expect companies to take them seriously," said FDA Commissioner
David A. Kessler, M.D. "Medical devices can save lives, but they
can also injure patients if they are not properly manufactured."

Although Infusaid had FDA approval for its original pump, it is
required by law to get approval for changes that could affect
safety and effectiveness.  In this case, changes were made in the
design, the material used and the packaging without FDA approval.

Between November 1990 and November 1991, Infusaid made 1,591
shipments of the unapproved pump.  In December 1991, after
numerous complaints, the firm recalled all the pumps. Those now
on the market have been re-designed and approved by FDA.

FDA is one of eight Public Health Service agencies within HHS.