Scalpel Weekly News

Week of: May 04, 2015

IN THE NEWS


Medtronic Cited for Ongoing Infusion Pump Violations

The FDA announced the filing of a consent decree against Medtronic, Inc., and two of the company’s officers for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems. These pumps are medical devices that deliver medication to treat primary or metastatic cancer, chronic pain, and severe spasticity. The violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured. Click title to continue reading...


 
MEDICAL ALERTS


Nationwide Mucinex Recall Due to Mislabeling

RB (formerly Reckitt Benckiser) of Parsippany, NJ, has recalled certain lots of liquid bottles of Mucinex Fast-Max Night Time Cold & Flu; Mucinex Fast-Max Cold & Sinus; Mucinex Fast-Max Severe Congestion & Cough; and Mucinex Fast-Max Cold, Flu & Sore Throat. These over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer. Click title to continue reading...



Ebola Virus Tests Lack Reliability; Life-Threatening Use Risk

All lots of the Ebola Virus One-Step Test kits have been recalled. The tests were distributed by LuSys Laboratories, Inc., San Diego, CA. The affected devices were sold in California and exported internationally to Sierra Leone, Canada, and Denmark between October 2014 and January 2015. The tests are intended for use as an aid in the diagnosis of Ebola Virus infection. Click title to continue reading..



One in Five Occupational Injuries Occur to Health Care Workers

In 2013, the health care and social assistance sector accounted for the greatest proportion (20.7%) of private industry nonfatal occupational injuries among all sectors. The most common injuries were due to patient handling; slips, trips, and falls; and workplace violence. In 2011, U.S. health care personnel experienced seven times the national rate of musculoskeletal disorders compared with all other private sector workers. Click title to continue reading...


  CASE ALERTS


Expert’s Report Demonstrated Causal Relationship Despite Conflicting Statements

A month after his birth, a boy was examined by his doctor at a regular checkup. The boy had a fever of 100.2 degrees, was coughing and suffering from nasal congestion, and had been exposed to sick contacts at home. He had been coughing to the point that he could not breathe and was exhibiting facial discoloration. The doctor did not order any tests at this appointment. Four days later, the boy’s parents brought him back to the doctor because his symptoms had worsened. The doctor physically examined the boy, but again did not perform or order any tests. Five days later, the boy’s parents took him to the hospital, where he was treated for acute pneumonia, wheezing, and tachycardia. He was transferred to another hospital where he died 40 days after his one-month checkup. Click title to continue reading...



Claims Against Compounding Pharmacists Are Health Care Liability Claims

A woman had been diagnosed with Hepatitis C. The doctor treated her for her Hepatitis C symptoms and prescribed and administered weekly intravenous injections of 200 mg/ml lipoic acid, an antioxidant supplement. She underwent nine weeks of treatment without incident. However, she suffered a severe adverse reaction while receiving her tenth lipoic-acid treatment. She was hospitalized for several weeks, received multiple blood transfusions, and became permanently blind in both eyes. Click title to continue reading...



No Exception to Peer Review Privilege for Objective Facts in Incident Report

A heart surgeon performed a cardiac catheterization on an 80-year-old woman. Immediately following the procedure, the woman began moving her legs around and rolled off the operating table. A nurse and lab technician caught the woman and lowered her to the floor. At that time, the woman denied hitting her head. Later, she complained of neck and back pain from the fall. The CT scan performed later that day showed no evidence of injury from the fall. Shortly after the surgery and fall, the woman died. Click title to continue reading...