Important Safety Alerts

The Health Sciences Authority (HSA) of Singapore has posted a medical device safety alert concerningAlaris Pump module model 8100, manufactured by BD. The affected devices are identified as follows:-

• Alaris Pump module model 8100 (Large Volume Pump) manufactured or serviced by the BD Service Depot from June 2002 to June 2004.
• Alaris Pump module door latch kit (P/N 147503-000) shipped from June 2002 to June 2004

The manufacturer has identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations:

1. the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and
2. opening the pump door using an atypical technique with the door latch with the centered sear design.

The user can reproduce a free-flow condition if the clinician does not close the roller clamp on the IV administration set prior to opening the pump door and the pump door is opened by using a flick of the door latch that causes the door to pop open instead of opening the door by slowly raising the latch. This flicking motion may cause the centered sear design to not effectively engage with the safety clamp fitment.

Both of these actions leave the roller clamp and safety clamp fitment in the open position which can cause unintended flow possibly resulting in an over infusion to the patient. The affected product is the centered sear door latch manufactured between June 2002 to June 2004.

According to the manufacturer, safety clamp fitment inactivation due to non-optimal engagement of sear to the slide clamp could result in an over infusion. Over infusion can result in serious life-threatening patient injury.

To prevent this from occurring, users are advised to close the roller clamp prior to opening the pump door, all dedicated intravenous administration sets have a warning tag affixed to the tubing and the front cover of the pump module has a warning stating "Close clamp before opening door" to assure that the roller clamp is properly closed. This is also instructed in the Alaris system User Manual.

Users are also advised to visually examine the affected device to determine if the door latch has a centered-sear flange (the door latch mechanism may have been replaced after manufacture with an off-centered sear design). The centered-sear safety clamp fitment is identified by the centered position of the metal pivot post located on the inside of the door latch assembly sear flange:-

• If the device has a centered-sear safety clamp fitment, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module. Notify the manufacturer to coordinate an onsite remediation or send the devices to the manufacturer's service depot.
• If the device has an off-centered safety clamp fitment, the device does not require remediation.

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

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 26 July 2017