Insulin infusion pump

Insulin Infusion Pump from Animas Recalled Due to False Alarm

There has been a Class I Recall on the Animas 2020 Insulin Infusion Pump. These machines are manufactured to pump insulin directly into a person’s bloodstream. They are used by people who have insulin issues related to a diagnosis of diabetes. This recall was listed during the first week of April and was issued by the Food and Drug Administration (FDA).

Insulin infusion pumpThe pumps manufactured from March 1 to November 30 of last year (2012) are the ones that have their functionality in question. According to FDA safety information, a component of the machine could possibly sound a false alarm. The alarm may be falsely alerting the user to problems concerning “loss of prime,” “occlusion” or “no cartridge detected.”

If one of these alarms sounds, the user might be instructed to “rewind, reload and prime” the unit. Caution is necessary when performing these steps because if you do not first unhook the pump from the body, it could cause extra insulin to be deposited into the bloodstream. This could cause serious injury, or even death, because of illnesses, such as hypoglycemia, that may occur.

There is also a flaw in the software system of this product. The machine will only work until December 31, 2015. After that date, it will stop pumping insulin and make a “Call Service Alarm.” The company, Animas, is offering advice as well as recommendations to people using this pump.

The company states that if a person has this machine that they should call the Product Fulfillment Center. They are open from 6 a.m. until midnight to be accessible to those customers dealing with problems relating to this recall. The company will send out a free replacement for the faulty pump.

Also, the company wishes that any patient with side effects relating to this issue report those problems. You can report these problems with an online report from the FDA, or clients may download or request forms by mail. Anyone with questions or concerns of any variety is encouraged to call the Fulfillment Center or Technical Support Center.

Related Sources:
http://www.ivteam.com/animas-corporation-2020-insulin-infusion-pump-class-i-recall-false-alarm-or-warning-sound/
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm