U.S.A.'s interesting news..

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error

AUDIENCE: Risk Manager, Nursing

ISSUE: CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death.

• Product Numbers:  147083-102, 49000221
• Manufacturing Dates: October, 2011 to June, 2015
• Distribution Dates: October, 2011 to June, 2015
• Devices Recalled in the U.S. 349,746 units

BACKGROUND: The Alaris Syringe Pump is an infusion pump that delivers fluids, such as nutrients, blood and medications, into a patient’s body in controlled amounts. The syringe holds the solution, and the infusion tubing connects the syringe to the patient through intravenous or enteral access. The device is indicated for use in adults, pediatric patients, and infants and only used in hospitals and other health care facilities.

RECOMMENDATION: On December 2, 2016, CareFusion sent a “Medical Device Safety Notification” to affected customers. The notice instructed that if an AIL alarm occurs; the user should do the following:

1. Determine if there is air visible in the tubing that has caused the alarm to go off. If there is air visible in the line, press the “Restart” key to advance the air bubble past the sensor. Evacuate the air from the tubing according to your standard practice.
2. If no air is visible, ensure that the tubing is installed correctly in the AIL sensor. When inserting the tubing into the AIL sensor, use a fingertip and firmly push the tubing toward the back of the AIL sensor.
3. If the AIL alarms continue to reoccur on the same pump, after air has been removed from the line and the tubing has been correctly installed, the AIL sensor may be faulty. The health care provider should remove the pump from service, and notify CareFusion. If the AIL sensor needs to be replaced, CareFusion will provide replacement parts at no charge.
4. Review the AIL tip sheet that provides instructions on troubleshooting problematic AIL alarms.
5. Access the AIL video that provides instructions on troubleshooting problematic AIL alarms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm540869.htm

Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

AUDIENCE: Pediatrics, Cardiology, Critical Care Medicine

ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter.

Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall.

BACKGROUND: Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. The product is packaged in three 2 mL Single-Dose vials per carton.

• NDC 39822-1030-2
• Lot PLND1613
• Expiration Date 02/2018

The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.

RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. Consumers/distributors/retailers that have the Ibuprofen Lysine Injection which is being recalled should stop using and return to their wholesaler/distributor, or to X-Gen or to Exela.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm540828.htm

Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids

AUDIENCE: Consumer, Emergency Medicine

ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death. These risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent.

See the Press Release for product photos.

BACKGROUND: Product was distributed to: MA, NJ, NY, IL, MD, FL, MO, TX, IN, GA, DE, CO, VA, PA, CT, OR, VA, AZ, and through vendors such as oriental herb stores, acupuncture clinics, and Oriental supermarkets. These retail businesses distribute to their individual customers.

The item is packed in a plastic brown bottle with white cap. Each bottle contains 100 Tablets, each tablet is 300mg.

RECOMMENDATION: Consumers who have purchased the product are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (718) 366-2300, Monday to Friday, 9:00am to 5:00pm.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm540773.htm

Need advice on buying a home or is renting better for your current family situation? Perhaps you want to consider a reverse mortgage. Get answers to your housing-related questions from the Department of Housing and Urban Development (HUD) certified housing counseling agencies.   Check out this video to learn more about how to contact a HUD sponsored housing counseling agency and how a counselor can help you. Are you thinking of becoming a homebuyer? Get more information on a Federal Housing Administration Loans (FHA) at USA.gov.

Do you work for a company's payroll or human resource department? Make sure to double check any unusual requests for lists of Forms W-2 or Social Security numbers. This could be cybercriminals trying to steal data to impersonate taxpayers.         Check out Taxes.Security.Together for tips to protect your data and avoid tax scams, including identity theft. Get answers to top questions about filing taxes, refunds, and more at USA.gov.