KCER Response to the Earthquake in Haiti

Since the catastrophic earthquake outside of Port-au-Prince on January 12, KCER has been working with the international renal community to provide coordination and support. This collaboration includes the American Society of Nephrology, the Latin American Society of Nephrology, and the International Society of Nephrology.

KCER volunteers and strategic planners include dozens of kidney-related companies, associations, and organizations who were able to contribute money, supplies, and volunteers to assist in the Haiti relief.

Originally formed in response to the devastating 2004 and 2005 hurricane seasons, KCER is a volunteer-based coalition of healthcare providers, government representatives, hospitals, patients, patient-centered organizations, and renal professional associations. KCER activities include patient education and staff training on disaster preparedness; promoting awareness to the emergency management community; and supporting the End Stage Renal Disease (ESRD) Network Program.

The KCER Coalition provides technical assistance to facilitate comprehensive, timely, and accurate information dissemination to the renal community and disaster response agencies. KCER provided situation reports, maps, and daily conference call coordination.

Responding to the needs in Haiti strengthens KCER's ability to respond to disasters in the U.S. impacting ESRD providers and patients. This crisis will raise awareness of the critical needs of kidney patients during a disaster. Following the earthquake, dialysis units were destroyed and patients were unable to receive regular dialysis treatments. This situation is compounded by acute kidney injuries from "crush syndrome" which may also require dialysis treatment.

Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org. President Bill Clinton and President George W. Bush have established the Clinton Bush Haiti Fund for donations for the relief and support of Haiti. The American Red Cross http://american.redcross.org is working with its partners to assist those affected by this disaster. To contribute, please visit the Red Cross online. The U.S. Government urges citizens to not self-deploy to the area. KCER encourages healthcare workers to join their local Medical Reserve Corps.

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.

The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

The company received reports of clinically significant fluid imbalance.

When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient.

In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius.

For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump).

These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.

This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment.

FDA has been apprised of this action. No injuries have been reported to date.

Product was distributed nationwide, including Puerto Rico.

Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.

Consumers with questions may contact the company at 305.599.7174 x249.

Helping Haiti

President Bill Clinton and President George W. Bush have established the Clinton Bush Haiti Fund for donations for the relief and support of Haiti.

The American Red Cross is working with its partners to assist those affected by this disaster. To contribute, please visit the RedCross online.

Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org.

For more ways to help, visit the Center for International Disaster Information (CIDI) site.

For information about disaster relief in Haiti, please visit

www.usaid.gov
www.state.gov
www.reliefweb.int
ICRC Family Links
Translated Haitian Creole Health Information
www.doctorswithoutborders.org
http://new.paho.org/disasters/

To donate goods or to volunteer:http://cidi.org/reg_offr.htm

For missing U.S. citizen family members: http://www.state.gov/p/wha/ci/ha/earthquake/index.htm

If you are a U.S. dialysis facility who is treating a victim of the earthquake in Haiti, please contact your local ESRD Network.