Important Safety Alerts

The Health Sciences Authority (HSA) of Singapore has posted a medical device safety alert regarding Alaris System PC unit Model 8015, manufactured by BD.

According to the safety alert issued by the manufacturer, System Error 255-16-275 can occur when a user selects two functions at the same time/rapid succession or not following typical workflows. This results in a synchronization issue between the PC unit and the modules. Below are five examples:

• Closing the pump module door and in rapid succession (less than 1 second apart) pressing START.
• Priming and starting system in PAUSE state and then attempting to remove the new syringe.
• Starting an infusion using the DELAY OPTIONS. Then confirming the delay entry and pressing CHANNEL SELECT on another module at the same time.
• Locking PCA door before confirming on screen popup that occurs on another module.
• Pressing CHANNEL OFF on two syringe modules after completion of infusions at the same time.

The System Error would result in a non-silence-able, high priority alarm and status indicator lights on modules will flash red. The PC unit displays an error code of 255-16-275. If the system error occurs, all attached modules that are actively infusing will continue to infuse without the ability to titrate infusion parameters. The user may decide to reboot the system or re-program the device to titrate the infusion and/or to silence the alarms. This could result in the clinical decision to interrupt the infusions. An interruption in infusion can result in serious injury.

The affected Alaris System will not need to be remediated. Affected users are instructed to refer to the User Manual Addendum to avoid the occurrence of this System Error.

For details, please refer to the HSA website:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Product_Owners_FSN/2017/june.html

Posted on 26 July 2017