From: Monika Warren, COO, Provincial Coordinated Health Services & CNO and Dr. Jose Francois, Provincial Chief Medical Officer

This alert is to highlight the importance of communicating which acetylcysteine (also known as N-Acetylcysteine, or NAC, or Mucomyst) dosing protocol is initiated upon any transfer between We are aware of a large volume of product complaints and reported patient safety events related to the B. Braun Infusomat pumps. Concerns reported include pump performance, tubing quality and impact to both patient and staff safety.

These pumps are in use at facilities and in various clinical environments across the province.

All reported safety events are being actively reviewed and managed and we cannot overstate the importance and value of continuing to document, report and respond to these safety events.
We recognize that completing the necessary documentation is an additional burden being placed on our clinical staff and we are sorry that it is adding to workload. Input from staff and clinicians is identifying issues across the system so that we may investigate and recommend mitigation strategies to support ongoing safe patient care. We continue to encourage staff and clinicians to raise and document these events as they occur.

We have been in contact with colleagues in other Canadian provinces and in other jurisdictions around the world. We can share that the feedback received mirrors what has been shared during these conversations and we are working provincially to share knowledge and information gained from those who have been managing these risks as effectively as possible for their staff and patients.

We are regularly engaging with the vendor to share our concerns and identify areas where we require their support and remediation but are also looking at all possible longer-term solutions, including potential fleet replacement.

We have heard the concerns shared over the past number of months from teams across the province and acknowledge the efforts have made to support immediate solutions and other mitigation strategies. We share your frustration with the ongoing challenges.

It is important to acknowledge that longer-term solutions will take time, requiring supply chain logistics, fleet testing, creation of drug library and pump deployment strategies, so while all options are being considered for the long-term, we continue to identify, test and implement interim measures, processes and workarounds to ensure the safety of our patients and to support all staff and clinicians working with this equipment.

A number of these processes have been developed and are recommended for use provincially, with implementation at the discretion of each site/SDO.

We are currently trialing the following measures:

• Other jurisdictions in Canada have suggested use of a port below the level of the pump to purge air in line as a syringe method (for non-hazardous medications or fluids only);
• We are trialing and adapting the use of ported IV sets for norepinephrine, so we can use a syringe method to remove air in line; and
• We have implemented a two-pump protocol for norepinephrine; this provides a backup medication delivery option if an air in line alarm occurs and stops the infusion.
• We have tested Fresenius pumps in select environments and will be recommending a further trial of this equipment in locations across the province to allow for your input and experiences to be contributed to our longer-term planning.

These are the latest in a long line of mitigation efforts that have been taken to address the challenges with this equipment. We recognize these strategies are not sustainable for the long-term and will share more information as longer-term options are identified.

Safety reports and product complaints strengthen our communication with Health Canada and provide the details that we need in order to identify and advocate for better solutions. Please continue to submit these.

We care for the professional integrity and wellbeing of our teams and clinicians. We know that these challenges are creating concerns for clinical and patient safety that is felt deeply.

We are moving as quickly as possible to identify interim and longer-term solutions and thank you for your ongoing commitment to patient safety and quality of care during this challenging time. We commit to keeping you updated and apprised as we work through the issues and long term possible solutions.

Please continue to raise concerns or suggestions for management of these practice concerns to your manager, team lead or to myself or Dr. Francois directly.

Submitted by: Tamara Burnham, Collaborative Practice Lead