NEWS
11/23/1993

<TITLE>FDA Announces Fine against Infusaid Inc.</TITLE>
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P93-43                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285


     The FDA today announced that the manufacturer of an
implantable infusion pump, used to give patients drugs, has agreed
to pay a $290,000 fine 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 model 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 
                             -MORE-

ATTENTION TV BROADCASTERS:  Please use open caption for the hearing
impaired.

                                        Page 2, P93-43, Infusaid
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.
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