What We Do
Defective Medical Products
- Medicines
- Accutane Lawsuit
- AMO Complete Moistureplus Recall
- Apothecure Colchicine Lawsuit
- Baxter Heparin Recall and Lawsuit
- Bayer Lawsuit
- Bismacine Chromacine
- Botox
- Carbinoxamine
- Chromium Poisoning (Toxicity)
- Colchicine Recall Lawyer
- Colistimethate Lawsuit Lawyer
- Compounding Pharmacy Error
- Edetate Disodium
- Fentanyl
- Fentanyl Lawsuit
- Fentanyl Patch Recall
- Fentora
- Fleet Lawsuit - Phosphate Nephropathy Kidney Failure
- Fosamax Osteonecrosis Jaw
- Ketek Liver Failure
- Ortho Evra Birth Control Patch
- Pharmacist Malpractice
- Promethazine
- Rocephin Death
- Selenium Poisoning (Toxicity)
- Topical Anesthetic
- Total Body Formula Recall and Lawsuit
- Trasylol and Kidney Failure
- Trasylol - Lawyer and Lawsuit
- Trasylol Recall
- Tysabri Lawsuit - No Recall
- Tysabri Natalizumab
- Zelnorm Heart Attack Stroke Lawsuit
- Medical Equipment
- Medtronic Defibrillator Leads
- Medtronic Lawsuit
- Medtronic Lawyer
- Guidant Recalls
- Free Guidant Recall Consultation
- Guidant Ancure
- Guidant Lawsuit Recall
- Guidant Pacemaker Defibrillator Defect
- Guidant Pacemaker Recall
- FDA Pacemaker Defibrillator Statement
- Infusion Pump
- FDA Recalls
- News & Topics
- Archives
- Alaris Infusion Pump Signature Edition
- Azathioprine Recall
- Blackstone Recall
- Dermafreeze Recall Pseudomonas Aeruginosa
- Disentronic Power Pack Recall
- External Monitor Defibrillator
- Neurostimulators MRI
- Prostate Biopsy Device
- Recall AED20 Automatic External Defibrillators
- Recall_Infusion Pumps
- Renal Replacement Recall
- Tissue Implant
- Triaminic Vapor Patch Recall
Welcome to Pritzker | Ruohonen
Alaris® SE Pumps
Alaris® SE Pumps (formerly the Signature Edition Infusion Pumps) may cause serious harm or death. According to Cardinal Health, owner of Alaris Products, a “key bounce” in the Alaris infusion pumps may cause over-infusion of medications, possibly 10 times the amount intended. Upon the request of the FDA, the United States Marshall has seized defective infusion pumps made by Alaris Products (see August 28, 2006, FDA press release).
If you have been injured during a medical procedure where an Alaris Infusion Pump was used, contact a lawyer at Pritzker | Ruohonen for a free consultation. Lawyer Fred Pritzker has over 29 years of product liability lawsuit experience. He is a member of the American Board of Trial Advocates and the Million Dollar Advocates Forum. In recognition of his achievements, he has been selected by his peers for inclusion in the 2005-2006 edition of The Best Lawyers in America. To contact Pritzker | Ruohonen, call toll-free at 1-888-377-8900, e-mail info@pritzkerlaw.com, or fill out our online consultation form.
FDA Press Release (August 28, 2006): United States Marshals Seize Defective Infusion Pumps Made by Alaris Products--Pumps Can Deliver Excess Medication and Harm Patients
At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August 25. The seized infusion pumps have a design defect called "key bounce" that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris' manufacturing facility are not distributed unless the problem is corrected.
Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended infusion rate. For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If not detected during programming verification, key bounce events may result in serious patient harm or death.
FDA inspections revealed that Alaris failed to follow FDA's medical device manufacturing regulations. The infusion pumps were seized by the U.S. Marshals Service at Alaris' manufacturing facility in San Diego, California. The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from facilities or individual users, and there are no plans to do so.
Alaris was issued warning letters by FDA in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but failed to take appropriate actions.
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Firm News
Fred Pritzker Listed in The Best Lawyers in America
Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.
Pain and Suffering
Rich Ruohonen recently chaired a legal seminar on obtaining compensation for pain and suffering in a personal injury case. Rich uses his knowledge, experience, and reputation to maximize recoveries for clients.
Medtronic Recall and Medtronic Lawsuit
FDA has annonced a Medtronic Spring Fidelis defibrillator lead recall. Two of our clients with defective Medtronic leads were shocked over twenty times before medical professionals were able to turn off the defibrillator.
Fleet Lawsuit
We are representing several people who experienced kidney failure (acute phosphate nephropathy) after use of Fleet Phospho-soda solution or Fleet Accu-Prep solution for bowel cleansing.
Ortho Evra Lawsuit: Ortho Evra Birth Control Patch
The Ortho Evra birth control patch has been linked to an increased risk of blood clots that can lead to pulmonary embolism, stroke and heart attack.
Trasylol Recall
Bayer has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
Fentanyl Lawsuit and Fentanyl Recall
There have been a number of recalls regarding fentanyl due to the risk of a fentanyl overdose.
Fosamax and Osteonecrosis
Several cases of bisphosphonate-associated osteonecrosis of the jaw have been associated with the use of oral bisphosphonates, including Fosamax®, Actonel®, and other medications.