[some had seizures]
http://www.aboutlawsuits.com/medtronic-paradigm-recall-quick-set-infusion-sets-4810/#comment-7518
Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps
July 13th, 2009 • Filed Under: News • 32 Comments
feature photo
Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.
The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.
The affected infusion sets have a lot number starting with “8” marked on the product box label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. The defective infusion sets do not vent air pressure properly when delivering an insulin dose.
The sets were distributed throughout the United States and to a small number of countries outside of the U.S., such as Germany, Mexico, Brazil, Great Britain, Canada and the Bahamas. There have been no reported injuries related to the insulin pump infusion set recall, but the defect has the potential to cause fatal injury.
Last month, the FDA issued a warning letter to Medtronic about Synchromed and MiniMed pump problems. The agency warned the company that it needed to fix quality control issues in its Puerto Rico plant where the products are manufactured. According to FDA investigators, the plant had a wide range of problems that included lax testing of products for defects, proper record keeping, and employing someone with only a high school education and some special training as a medical expert for determining the danger of defects.
Medtronic is offering patients replacement Quick-set infusion sets for the MiniMed Paradigm insulin pumps in exchange for the defective ones at no charge. However, product liability lawyers who are investigating potential lawsuits for Medtronic insulin pump problems caused by the recalled Quick-set infusion sets, indicate that any units from the recalled lots should be preserved for litigation purposes if a serious or fatal injury has occurred.
many comments on product.....
http://www.bearridgeproject.com/2009/06/bed-is-bouncing.html
Thursday, June 25, 2009
The Bed Is Bouncing
On a few occasions I have been awoken in the early morning hours by a low noise that can best be described as a diesel truck idling outside the house the noise has been accompanied by a gentle pulsing that you can actually feel in the bed and even standing in the middle of the house. I have heard this noise probably five times usually around three in the morning. The dogs can also hear the noise and twice they woke me with their growling.
Last night about one in the morning I woke up to the bed pulsing and I heard the low hum of the big truck the dogs were both awake and growling. I got up and went out on the front porch and could still hear and feel the phenomenon. It was a calm clear night and the noise seemed to come from everywhere. I pulled on my boots, grabbed a flashlight and went up on the ridge to see if maybe there was a truck idling on the other side of the hill. Found nothing but the coyotes were going crazy yelping. Could still hear and feel the rhythmic pulse.
I am currently using the backup inverter and I shut if off when I go to bed so there is nothing powered in the house that can vibrate. It is not a helicopter or C130 cargo plane. Both of these frequently fly over very low transporting between Los Alamos and Colorado Springs usually at night. They also wake me up. I have heard it on windy nights but last night it was calm.
As best as I can tell this is the Taos Hum which is a world wide phenomenon that manifests itself as a low throbbing noise in very quiet parts of the world. I have talked with a few neighbors they and their animals also experience the “hum” usually around three in the morning.
It’s not really annoying just kind of weird.
Posted by BigBear at 5:45 AM 15 comments
Labels: Life