Fresenius Urgent Recall for AC Power Cords

Fresenius Medical Care is initiating a recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord manufacturing company. This alert is being issued in response to a FDA Alert regarding customer reports of sparking, charring and fires of similarly designed AC power cords in non-dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri-Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs). The potential risks from power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires, which may be exacerbated in an oxygen rich environment. Depending on the device, therapy, and environment, these failures may lead to potential serious injury or death. Fresenius Medical Care NA has not received any reports of serious patient harm related to the situation. Visit www.fmcna.com or www.fda.gov for more information.

Preparing for the Next Disaster: Dialysis Community Briefs Hill About

PRWeb Press Release News Wire

Preparing for the Next Disaster: Dialysis Community Briefs Hill About Emergency Response

"Dialysis patients represent one of the most at risk segments of the population during a natural disaster," said Bill Numbers, Vice President of Operations Support and Incident Commander for Disaster Planning and Response at Fresenius Medical Care North America (FMCNA).

Washington, D.C. (PRWEB) February 26, 2009 -- "Dialysis patients represent one of the most at risk segments of the population during a natural disaster," said Bill Numbers, Vice President of Operations Support and Incident Commander for Disaster Planning and Response at Fresenius Medical Care North America (FMCNA). Numbers was in Washington to speak with an audience of congressional staffers focused on safeguarding the lives of dialysis patients in a natural disaster. The event, said Numbers, should remind everyone that "we always need to be ready and we must constantly work to be better prepared."

The briefing organized by the Kidney Community Emergency Response Coalition and Fresenius Medical Care looked at the problem of Chronic Kidney Disease (CKD) as well as ongoing emergency response and recovery efforts. With CKD rates skyrocketing, Chief Medical Officer and Senior Executive VP for FMCNA, Dr. Michael Lazarus explained that educating the public, policy-makers, and emergency response teams is more important than ever. Looking at data for the period between 1997 and 2006, Lazarus pointed to across-the-board increases in CKD rates:
• 106% for Hispanic Americans.
• 98% for Asian Americans.
• 55% for Native Americans.
• 49% for African Americans.
• 42% for Caucasians.

Since Kidney patients typically need four hours of dialysis three days each week in order to eliminate waste, toxins and extra fluids from their system, these increases also underscore the need for emergency planning. Any interruption caused by storms, floods, fires, earthquakes and other natural disasters that might affect electrical power, water lines or make routine travel impractical is life-threatening.

Thinking ahead is even more important than ever. "We're lucky that the dialysis community and emergency responders are working together to prevent the loss of lives," said Bill Numbers. "We simply need to ensure that we are doing everything we can, including educating the public."

Since March is National Kidney Month, briefing organizers hope to focus attention on the impact of natural disasters on dialysis patients. They also want the public to know what is already being done. Kelly Mayo, Project Director, Kidney Community Emergency Response Coalition, spoke about her organization's work with dialysis providers around the country. And Numbers described the evolution of FMCNA's response and recovery efforts, beginning with the Northeast power outage in 2003 through Hurricane Ike and Gustav. In 2008, Numbers said over 100 clinics and 8000 patients were affected during the 3 hurricanes in August through September 2008. During that time, Fresenius provided care to more than 500 non-Fresenius patients and brought in 4 large generators and diesel fuel to supplement local alternative power in Houston and Beaumont communities.

Reflecting on the importance of response and recovery efforts by Fresenius, KCER, and others, Bill Numbers said: "We are committed to doing this whenever we have to and at whatever the cost. When it comes to dialysis patients, they have no options in a disaster. It is a huge responsibility to safeguard the lives of these individuals and families. And we will continue to work with government and other health providers to prevent the loss of life."

Kidney Community Emergency Response Coalition (KCER) mission is to collaboratively develop, disseminate, implement and maintain a coordinated preparedness and response framework for the kidney community in the event of any type of emergency or disaster. The KCER Coalition membership is open to anyone. To join the Coalition, visit our website and download a contact card or e-mail kcer(at)network7(dot)esrd(dot)net. Emergency preparedness resources and information on the KCER's current activities can be found on their website,
www.KCERcoalition.com.

Fresenius Medical Care (FMCNA) is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1.6 million individuals worldwide. Through its network of 2,297 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 177,059 patients around the globe.

Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P). More information can be found at: www.ultracare-dialysis.com.

Contact:
David Shapinsky
202-302-4904
dshapinsky(at)obassociates(dot)net

Notice: ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

The kidney community uses a variety of products and resources to ensure the health and safety of patients and healthcare professionals. The United States Food and Drug Administration (FDA) issues alerts and notifications when these products and resources are unsafe or being recalled.

As directed by CMS, the KCER Coalition issues notices on FDA recalls via email and this website for the kidney community. To join the email list, please email sburris@nw7.esrd.net.

November 6, 2008

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

ESRD Networks continue collaboration for tropical weather threats

The KCER Coalition is continuing daily communication with ESRD Networks, CMS, providers, and key stakeholders in the kidney community for the impact of Gustav and the threat of Hurricane/Tropical Storm Hanna.

The KCER website has been updated with information to include helpline numbers and information for Hanna.

As always, everyone should monitor conditions through the National Hurricane Center, your local weather service office, your local emergency management agency, and local news media for information specific to your area.

www.kcercoalition.com

KCER Monitors Tropical Weather Threats Gustav, Hanna

The KCER Coalition is actively monitoring Tropical Storm Gustav and Hanna. ESRD Networks, CMS, and KCER Response Team leaders are in communication regarding preparations for these storms.

We encourage everyone to continue to monitor the progression of Gustav through the National Hurricane Center: http://www.nhc.noaa.gov/, and their local weather service office and emergency management agency.

National Hurricane Center forecasts are typically issued every six hours (5am, 11am, 5pm, 11pm). Gulf Coast areas and Florida should monitor the forecasts, as they change daily and remember not to focus on "the skinny black line" of the projected landfall.

Mississippi Emergency Management Agency:
www.msema.org/

Louisiana Office of Homeland Security And Emergency Preparedness:
www.ohsep.louisiana.gov/

Texas Division of Emergency Management:
www.txdps.state.tx.us/dem/pages/index.htm

Alabama Emergency Management Agency
http://ema.alabama.gov/

Florida Division of Emergency Management
www.floridadisaster.org/index.asp

Florida Wildfires

The Kidney Community Emergency Response (KCER) Coalition is currently monitoring the wildfire situation in Florida.

If you are in the impacted area, it is vital to listen and obey your local officials' emergency orders. Most importantly, evacuate if you are told to do so. For individuals with kidney failure, remember to take your medicines, medical records, supplies, food, and insurance information. Call your dialysis clinic and tell them that you had to evacuate and tell them where you are staying.

Wildfires can also cause problems even if you are not in the impacted area. Smoke can reduce visibility on roads which can cause traffic accidents or close important roads. Make sure you know alternate routes to reach your dialysis facility, pharmacy, or family member's home.

The wildfire smoke can hurt your eyes, irritate your nose/throat/lungs, and can worsen illness. If you have respiratory problems, try to stay indoors away from the smoke. For more information, visit the Wildfire Smoke Health and Safety page from the Arkansas Division of Air Quality.

For information about wildfire safety, visit the American Red Cross site http://www.redcross.org/services/disaster/0,1082,0_594_,00.html