BCI Remote Cable Recall Issued Due to Alarm Failure
Several lots of BCI alarm cables needed to activate life-saving alarms in hospital settings could fail, potentially posing a risk of severe injury or death for patients, federal health officials warn.
The FDA issued a class 1 recall for BCI remote alarm cables this week after the manufacturer, Smiths Medical, became aware that the cables were not transferring alarms with some remote nurse alarm systems.
A class 1 recall is the most serious type of medical device recall, and is only issued when there is potential that the product in question may cause serious injury or may result in death. To date, there have been no reported cases of serious injury or death associated with the recalled BCI cables.
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BCI alarm cables are used in critical care situations to connect to remote nurse alarm systems used in ventilators, patient transport and anesthesia machines for pediatric and adult uses. The nurse alarm systems are used to notify healthcare workers in the event of serious adverse events or in cases of medical necessity, such as monitoring elevated pulse, high blood pressure and ventilator issues, among other problems.
The lot numbers of BCI alarm cables affected by the class 1 recall are W3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, and WW3398NC0947. They are designed to be used with 9004 Capnocheck Capnography systems to transfer alarm signals from Capnocheck Capnography systems to remote alarm system used for critical applications.
The recalled BCI cables were manufactured by Smiths Medical ADS in Saint Paul Minnesota and distributed to Colorado, Illinois, Indiana, Massachusetts, South Carolina and Wisconsin from October 2008 through Sept 2012.
Customer service agents from Smiths Medical originally issued an “urgent medical device field safety notice-recall” letter on February 6, notifying customers of the affected product, the problems with the cables, and actions customers should take.
They also instructed customers to inspect their inventory and remove the affected devices from use and to await contact from a customer representative with detailed instruction for returning products for replacement credit. Customers with questions can call (800) 258-5361.
EllenApril 11, 2013 at 3:24 pm
When My Mom was in KDMC in Ashland, KY. for 11 Days. The Alarms RARELY WORKED!!!!!
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