SAN DIEGO, May 27, 2015 /PRNewswire/ -- CareFusion, a
BD company (NYSE:BDX), provided an update on a global voluntary
recall that was initiated on April 21,
2015 to address an issue with certain units of
AVEA® ventilators.
The recall has been designated as a Class I recall by the U.S.
Food and Drug Administration (FDA), which means the Agency believes
that there is a reasonable probability that use of the recalled
product will cause serious adverse health consequences or death. To
date, no report of patient injury has been received related to this
issue.
The AVEA ventilator is only used in hospitals and other health
care facilities and is intended for continuous breathing support
for neonatal through adult patients. The recall is in response to a
potential malfunction of an AVEA ventilator specific 5 psi pressure
transducer. The affected AVEA ventilators may develop a failure
mode over a period of time, where, by design, the ventilator
activates false Extended High Ppeak or Circuit Occlusion audio and
visual alarms, opens the safety valve and stops ventilating. If
this occurs, alternate ventilation support will be required to
reduce the potential of hypoxemia or hypercapnia.
The global recall involves AVEA ventilators manufactured,
serviced and distributed from July 1,
2011 to March 15, 2015.
CareFusion learned of this issue through customer reports
identifying Extended High Ppeak or Circuit Occlusion alarms. A list
of affected model and serial numbers is available at the CareFusion
website. Refer to Figure 1 for the location of model and serial
numbers.
CareFusion puts patient safety first and will continue to work
diligently with customers and global regulatory authorities to
resolve this issue in a timely manner. The company has notified
customers of the recall with an urgent recall letter. The
CareFusion Recall Support Center is contacting global customers via
telephone to coordinate on-site AVEA ventilator correction in a
timely, effective manner.
The FDA and other regulatory authorities have been
notified.
Instructions to Customers
CareFusion does not require the return of affected AVEA
ventilators.
In the interim, if an AVEA ventilator exhibits a sustained
Extended High Ppeak or Circuit Occlusion alarm followed by the
opening of the safety valve that cannot be cleared by powering the
ventilator off and back on again, immediately remove the ventilator
from service, provide alternate ventilation and contact CareFusion
Technical Support at the contact information listed below to report
the issue.
Customer inquiries related to this action should be addressed to
the CareFusion Recall Support Center at 1.888.562.6018 or email
SupportCenter@carefusion.com between the hours of 6:30 a.m. to 5:00 p.m. PDT.
For technical support or to report a problem, please contact
CareFusion Technical Support at 1.800.231.2466 or email
Support.Vent.US@carefusion.com.
Adverse reactions or quality problems experienced with the use
of this product should be reported to the FDA's MedWatch Adverse
Event Reporting program either online, by regular mail or by
fax:
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178.
Countries with AVEA ventilators affected by the global
recall:
ISO
Code
|
Country
|
AL
|
Albania
|
AS
|
American
Samoa
|
AR
|
Argentina
|
AU
|
Australia
|
AT
|
Austria
|
BH
|
Bahrain
|
BD
|
Bangladesh
|
BB
|
Barbados
|
BE
|
Belgium
|
BZ
|
Belize
|
BM
|
Bermuda
|
BO
|
Bolivia
|
BA
|
Bosnia and
Heherzegowina
|
BR
|
Brazil
|
CA
|
Canada
|
CL
|
Chile
|
CN
|
China (People's
Rep)
|
CO
|
Colombia
|
CR
|
Costa Rica
|
HR
|
Croatia
|
CY
|
Cyprus
|
CZ
|
Czech
(Rep)
|
DO
|
Dominican
Republic
|
EC
|
Ecuador
|
EG
|
Egypt
|
SV
|
El
Salvador
|
EE
|
Estonia
|
FR
|
France
|
GE
|
Georgia
|
DE
|
Germany
|
GB
|
Great
Britain
|
GR
|
Greece
|
GT
|
Guatemala
|
HN
|
Honduras
(Rep)
|
HK
|
Hong Kong,
China
|
HU
|
Hungary
(Rep)
|
IN
|
India
|
ID
|
Indonesia
|
IE
|
Ireland
|
IL
|
Israel
|
IT
|
Italy
|
JP
|
Japan
|
JO
|
Jordan
|
KR
|
Korea
(Rep)
|
KW
|
Kuwait
|
LV
|
Latvia
|
LB
|
Lebanon
|
LY
|
Libyan
Jamahiriya
|
LT
|
Lithuania
|
MY
|
Malaysia
|
MX
|
Mexico
|
MD
|
Moldova (republic
of)
|
KR
|
Korea
(Rep)
|
KW
|
Kuwait
|
MA
|
Morocco
|
NP
|
Nepal
|
NL
|
Netherlands
|
Nl
|
Nicaragua
|
NO
|
Norway
|
OM
|
Oman
|
PK
|
Pakistan
|
PS
|
Palestine
|
PA
|
Panama
(Rep)
|
PY
|
Paraguay
|
PE
|
Peru
|
PH
|
Philippines
|
PL
|
Poland
|
PT
|
Portugal
|
PR
|
Puerto
Rico
|
QA
|
Qatar
|
RO
|
Romania
|
RU
|
Russian
Federation
|
RW
|
Rwanda
|
SA
|
Saudi
Arabia
|
SG
|
Singapore
|
SK
|
Slovakia
|
SI
|
Slovenia
|
ZA
|
South
Africa
|
ES
|
Spain
|
TW
|
Taiwan
|
TH
|
Thailand
|
TN
|
Tunisia
|
TR
|
Turkey
|
AE
|
United Arab
Emirates
|
UK
|
United
Kingdom
|
UY
|
Uruguay
|
US
|
United
States
|
VE
|
Venezuela
|
VN
|
Vietnam
|
YE
|
Yemen
|
About CareFusion
CareFusion, a BD company, serves the
health care industry with products and services that help hospitals
measurably improve the safety and quality of care. The company
develops industry-leading technologies including Alaris®
infusion pumps and IV sets, MaxPlus® and
MaxZero™ IV connectors and sets, Pyxis®
automated dispensing and patient identification systems,
AVEA®, LTV® series and
AirLife® ventilation and respiratory products,
ChloraPrep® products, MedMined® services for
data mining surveillance, V. Mueller® surgical
instruments, and an extensive line of products that support
interventional medicine. For more information please visit
www.carefusion.com.
About BD
BD is a leading medical technology company
that partners with customers and stakeholders to address many of
the world's most pressing and evolving health needs. Our innovative
solutions are focused on improving medication management and
patient safety; supporting infection prevention practices;
equipping surgical and interventional procedures; improving drug
delivery; aiding anesthesiology and respiratory care; advancing
cellular research and applications; enhancing the diagnosis of
infectious diseases and cancers; and supporting the management of
diabetes. We are more than 45,000 associates in 50 countries who
strive to fulfill our purpose of "Helping all people live
healthy lives" by advancing the quality, accessibility, safety
and affordability of healthcare around the world. In 2015, BD
welcomed CareFusion and its products into the BD family of
solutions. For more information on BD, please visit www.bd.com.
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SOURCE CareFusion