Important Safety Information on Alaris Infusion Sets and Alaris 8100 Pump Module - Risk of Over-Infusion

Starting date:
April 28, 2019
Posting date:
May 30, 2019
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices, New safety information, Suspected quality concern
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-69764

Last updated:

Update – Thursday, May 30th.  The manufacturer Becton, Dickinson and Company (BD) has expanded the list of affected products to include all model codes and lot numbers with an expiration date between 05/2019 and 08/2020 inclusive. This is noted in Attachment 1 of the letter from BD (see link below). This expanded list of affected products is in addition to the original list of products affected (see list below). BD has also confirmed that the affected lots were distributed beginning in August 2018 and not in the beginning of November 2018, as previously indicated.

The updated Products Affected list and original letter from BD can be accessed at:

https://www.bd.com/en-us/support/recall-notifications/recall-notification-alaris-pump-infusion-sets

 

Audience

Healthcare professionals in hospitals and other healthcare facilities using volumetric infusion pumps

Key messages

  • Becton Dickinson (BD) has issued a recall of affected lots (see Products Affected below) on April 18th, of the Alaris Pump Infusion Sets due to a manufacturing defect that can cause unintended delivery which can result in over-infusion. BD has requested Canadian facilities to remove and destroy all affected products and is investigating whether additional lots may be affected.
  • While the investigation is ongoing, Health Canada is disseminating this safety information to other potentially impacted healthcare facilities.
  • Healthcare professionals should only use Alaris Pump Infusion Sets that have not been identified as part of the affected lots
  • As a precautionary measure, for all other infusion sets, not just those identified to date, Health Canada recommends that healthcare professionals:
    • During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time.
    • Always close the roller clamp when infusion is not intended.
    • Ensure the tubing is loaded according to the manufacturer’s instructions.
    • Open the roller clamp and verify that no fluid is dripping through the drip chamber before attaching the pump to a patient and initiating an infusion.
  • Health Canada continues to monitor the situation and will work with the manufacturer to provide an update if additional affected lots are identified.

    

Issue

What is the issue?

Health Canada has received reports of over-infusion with the Alaris Pump Infusion Sets used with Alaris 8100 Pump Module in Canadian hospitals. The manufacturer has confirmed that unintended delivery can be caused by defective Alaris Pump Infusion Sets. Unintended delivery of medications can cause serious patient injury, depending on the type of medication which is being delivered.

Unintended delivery can occur when the pump is in Pause mode, or can also result in a faster than expected drug delivery rate when the pump is infusing.

The manufacturer has issued a recall on April 18, 2019 of affected Alaris Pump Infusion Sets lots that have been identified so far and requested facilities to remove and destroy these products.

Products affected

Medical Device Name: Alaris Pump Infusion Set*
Manufacturer: BD Switzerland Sarl
Device Licence Number: 12161
Model Code Lot Number Expiration Date
2478-0000 18116061 November 22, 2021
  18116062 November 23, 2021
10015414 18115223 November 2, 2021
10933805 18116304 November 21, 2021
2420-0007 19023000 February 1, 2022
  19013155 January 31, 2022
  19013154 January 31, 2022
  18116500 November 22, 2021
  18115135 November 2, 2021
  18115088 November 2, 2021
2420-0500 18116640 November 22, 2021
  18116641 November 22, 2021
  18116703 November 22, 2021
2426-0007 18116575 November 22, 2021
  18116635 November 21, 2021
  18116647 November 22, 2021
  18116648 November 22, 2021
  18116657 November 22, 2021
  18116658 November 22, 2021
  18115006 November 1, 2021
  18115007 November 1, 2021
  18115132 November 2, 2021
2426-0500 18115003 November 1, 2021
  18115004 November 2, 2021
  18115129 November 2, 2021
  19013152 January 31, 2022
  19013153 January 31, 2022
  19023005 February 1, 2022
2477-0000 18115199 November 2, 2021
  18115200 November 2, 2021
2477-0007 18116521 November 22, 2021
  18116637 November 22, 2021
  18116638 November 22, 2021
  18116751 November 22, 2021
  18116752 November 23, 2021
*The Alaris Pump Infusion Set is used with the Alaris 8100 Pump Module (Device Licence Number 12364).

The manufacturer is in the process of identifying all affected Alaris Pump Infusion Sets that have been distributed in Canada. Health Canada will work with the manufacturer to provide an update if additional lots are identified.

Background information

The Alaris system is used in healthcare facilities for delivering fluids, medications, blood, and blood products. The Pump Module is indicated for use on adults, pediatrics and neonates.

Cases of patients requiring medical intervention following over-infusion with Alaris Pump Infusion Sets used with the Alaris 8100 Pump Module have been reported. Due to a manufacturing defect in some Alaris Pump Infusion Sets, the Alaris Pump Module mechanism is not able to fully occlude the tubing when it is supposed to. This incomplete occlusion can lead to unintended delivery when the pump module is not in running status with the roller clamp open or can result in faster than expected drug delivery flow when the pump is infusing.

Who is affected

Information for consumers

The Alaris Pump Infusion Sets and the Alaris 8100 Pump Module are used to deliver fluids, medications, blood and blood products.
The manufacturer has found that some of the Alaris Pump Infusion Sets are defective and can cause medications to be delivered when the pump is paused or delivered faster than expected. These infusion sets are only used in a hospital or surgical setting and won't impact any home IV therapy that patients maybe receiving.

The manufacturer is continuing to investigate if additional product lots are affected. Consumers should contact their healthcare providers for more information.

Information for healthcare professionals

The manufacturer has requested healthcare facilities to remove and destroy affected lots of the Alaris Pump Infusion Sets that have been identified so far as part of the recall.

Healthcare professionals should continue to be vigilant when monitoring infusions with the Alaris Pump Infusion Sets and Alaris 8100 Pump Module.

In addition, Health Canada recommends that users perform the following procedures when using these devices:

  • During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time. If there is less than expected medication remaining in the bag, or is the bag is empty before expected, an over-infusion event may have occurred.
  • Ensure that the roller clamp on the Alaris Pump Infusion Set is closed whenever infusion is not intended.
  • Follow the manufacturer’s step-by-step instructions when loading the Alaris Pump Infusion Set into the Pump Module.
  • Check that no extraneous objects are caught in the pump door prior to closing it.
  • Before attaching the pump to a patient, open the roller clamp and verify that no fluid is dripping through the drip chamber. If drips are observed, do not initiate infusion with the Pump Module unit and infusion set.

Action taken by Health Canada

Health Canada is working with the manufacturer to determine the cause of unintended delivery events and to identify all affected products that have been distributed in Canada. Health Canada will work with the manufacturer to issue an update if additional lots are identified or more information becomes available.

Health Canada is also communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website (https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php). This communication will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare providers and consumers reporting adverse reactions and medical device incidents. Any case of uncontrolled flow or other serious or unexpected medical device incidents in patients receiving infusions with Alaris Pump Infusion Sets and the Alaris 8100 Pump Module should be reported to Becton Dickinson or Health Canada.

Regulatory Operations and Enforcement Branch
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675

The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site. (http://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html)

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.