Scalpel Weekly News

Week of: September 01, 2014

IN THE NEWS


Recall of Infant Care Products Due to Mold; Possible Severe Injury

Children’s Medical Ventures received a number of complaints about visible mold on the outer surface of Gel-E Donut and Squishon 2 gel-filled products. The detected mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium has been known to cause several different types of invasive infections, including skin, eye, sinus, and brain infections especially in vulnerable populations such as neonates, critically ill patients, and patients with an impaired or weakened immune system. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or allergic reaction. Click title to continue reading...


 
MEDICAL ALERTS


Multi-Nation Vascular Retrieval Snare Recall; Metal Loop Breaks Causing Emboli

Cook Medical recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices. The device, model number VRS-6.0-9.0, was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare. Click title to continue reading...



Sheath of Atherectomy System May Fracture; Blood Flow Tool Recall

Cardiovascular Systems recalled certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly cause an embolism which might block the blood vessel under treatment or blood vessels further away. Click title to continue reading...



Multistate Outbreak of Salmonella Braenderup Linked to Nut Butters

The CDC is collaborating with public health officials in several states and with the FDA to investigate a multistate outbreak of Salmonella Braenderup infections. Results from this ongoing investigation indicate that almond and peanut butter manufactured by nSpired Natural Foods, Inc., is the likely source of this outbreak. Click title to continue reading...


  CASE ALERTS


Part of Kentucky Incident Report Not Privileged Under Federal Law

A woman underwent an elective spine surgery performed by three doctors at a hospital run by a health care system. On the day of the event, after the woman died, a hospital surgical nurse generated a post-incident or event report concerning the surgery through the health care system’s Patient Safety Evaluation System (PSES). Click title to continue reading...



Failed Tubal Ligation Resulting in Pregnancy; Limitations Not Triggered

A woman underwent a bilateral tubal ligation via electrocautery, a sterilization procedure in which the fallopian tubes are physically obstructed by using an electrical current to pinch the tubes closed. Based on her discussions with the doctor who performed the procedure, the woman understood that the procedure was a permanent birth control method making the odds of becoming pregnant without prior surgical intervention extremely low. In fact, the doctor indicated that the purpose of performing the tubal ligation was permanent sterilization. Click title to continue reading...



Plan Administrator Factual Errors Abused Discretion When Benefits Denied

An employee of a company was covered under the company’s health plan, which was governed by the Employee Retirement Income Security Act of 1974 (ERISA). The plan was self-insured by the employer, which was both the sponsor and administrator of the plan. The company contracted with third-party administrators to review claims made under the plan, including a third-party administrator responsible for reviewing mental health and substance abuse claims, and anorexia nervosa. Click title to continue reading...