Risk of leaks, chemo drug spills prompt CancerCare Manitoba to stop using some IV pump equipment: memo

CBC

11-03-2025

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Manitoba's cancer authority has stopped using an infusion pump line — made by a company whose IV pumps have been the subject of recalls — over concerns about leakage and the increased risk of potentially hazardous chemotherapy drug spills, according to a memo obtained by CBC News.
On Dec. 17, 2024, CancerCare Manitoba recommended community cancer care program directors and managers stop using B. Braun Cyto-Set lines in early 2025.
"Over the last year, there have been increased risks and concerns brought forward," the memo said.
B. Braun signed a service agreement with Shared Health in September 2021 to supply service delivery organizations, including CancerCare Manitoba, with large volume infusion pumps, IV and blood administration sets.
The Cyto-Set lines are specifically designed to deliver chemotherapy drugs to patients through intravenous therapy.
Issues with the lines include challenges with lack of compatibility with other IV equipment, leaking and increased hazardous spills, inconsistent supply with frequent shortages and lack of standardization with other equipment, according to the CancerCare memo.
CancerCare "has been working with [the] Shared Health Supply Chain to ensure a smooth transition of product from the B. Braun CytoSets to B. Braun Infusomat primary lines and the current provincial contracted Baxter secondary lines," the memo states.
The lines, or tubes, are hooked up to an IV pump which delivers fluids or doses of medications in a controlled way to a patient.
The B. Braun Cyto-Set lines being pulled by CancerCare have not been subject to a recall.
According to Health Canada, however, certain models of an IV pump made by the same manufacturer have been previously recalled by the company.
Recalled pumps a problem, worker says
The CancerCare memo said B. Braun Infusomat Space large volume infusion pumps have been in use in Manitoba for around a year and a half. Some models of these devices have been the subject of recalls in both Canada and the United States.
One front-line health-care worker, whose identity CBC has agreed to keep confidential over concerns their job could be affected by speaking publicly, said staff are wasting valuable time to make sure the recalled pumps work properly.
"It's just astronomical amounts of time and effort to infuse these drugs that traditionally we didn't even consider the time it took to use a pump or a line," the worker said. "They were just a tool that helped us do our job."
According to Health Canada, B. Braun Medical Inc. notified the department on June 12, 2024, about a recall of its Horizon and Infusomat space pumps.
"Devices distributed across Canada, including Manitoba, were included in the recall," Health Canada said in an email to CBC News. "The company reported that the backcheck valve of the device may malfunction, causing a backflow of medication from the secondary IV into the primary IV bag. It may also cause an inability to remove air bubbles from the tubing."
Between Dec. 1, 2019, and Feb. 28, 2025, Health Canada got 259 reports related to the recalled pumps. Of those reports, 243 came from Manitoba, a Health Canada spokesperson said.
Of the 259 reports received, one involved a death and 16 involved serious health deterioration. Health Canada won't say where in the country these incidents occurred, citing patient privacy.
B. Braun fixing problem in new devices
Health Canada said B. Braun is fixing the problem with the recalled pumps to prevent any issues in future manufacturing.
Written notifications were sent to individual customers and hospitals who have received the affected pumps.
"The notifications included specific instructions for clinicians for the continued use of the pumps, until new unaffected sets become available," Health Canada said. "B. Braun also specified that critical medications should not be given through second IV lines."
In an emailed statement, B. Braun told CBC News it deployed a team of clinical educators to provide enhanced product training at health facilities in Manitoba.
"As a result, the health systems in the province that implemented the recommendations, resolved the issues in questions," the company said.
But the Infusomat pumps are still causing problems, according to some medical providers.
The front-line worker who spoke confidentially said health-care staff members are struggling even with the workaround instructions shared by the company.
"We're having tons of issues as far as alarms going off on the pumps, air in line, downstream occlusions," the front-line worker said.
A downstream occlusion happens when a patient's arm is bent and the drug they're getting can't flow freely into their vein, but the worker said false alarms occur frequently with the pumps.
The worker said even if they follow the workaround instructions, the pump is so sensitive that it continually alarms, preventing them from getting medication into patients.
Health-care providers are encouraged to fill out incident reports when there are issues with the pumps, they said.
The front-line worker said concerns have been run up the chain of command within Manitoba's regional authorities but they feel not enough has been done.
"It's a tool we're supposed to use to administer these drugs and the tool itself is broken," the worker said.
B. Braun said any facilities still experiencing issues with the Infusomat Space pumps and associated administration sets, or lines, "have been resistant to implement the solutions."
"We have offered to revisit our education and training at those facilities on a number of occasions, including recently."
Nurses union concerned
Manitoba Nurses Union president Darlene Jackson said they've been hearing from members about concerns with the Infusomat pumps and lines ever since the province started using them.
"Issues with leaking, with improper valve closures," Jackson said.
She said the issues were raised through labour relations officers and workplace health and safety committees.
Jackson said it's a risk to have health-care workers or family members of patients inadvertently exposed to chemo drugs, because they kill both cancer cells and normal cells.
"These are cytotoxic drugs and they affect everyone that's in contact with them," Jackson said.
Jackson said dealing with the pumps is yet another challenge for nurses who are already faced with heavy workloads.
"It's a constant worry that the dose is going to be incorrect. If it's leaking, how much did I really give? If I've lost a quarter of the fluid, how much drug did the patient get and is the treatment going to be therapeutic?" said Jackson.
And when alarms go off on the pumps, she said it's difficult for nurses to know if it's because the device isn't working properly or because there's an actual issue with the delivery of a drug.
"If this alarm is going off and I can't see an issue that needs to be troubleshot, then your question is: can I trust this equipment?"
A spokesperson for Shared Health told CBC News it has engaged with "B. Braun to address end-user complaints separate and distinct from the September 2023 notice, some of which are related to Infusomat pumps and their accessories (CytoSet IV administration systems).
"Each alert or notice prompts a process in which Shared Health investigates every possible cause and explores every potential remedy in order to continue to prioritize and protect patient safety and support front line staff."
B. Braun pumps recalled in the U.S. in 2023: FDA
In an earlier recall, the U.S. Food and Drug Administration in November 2023 announced B. Braun was recalling more than 10,000 Infusomat Space large volume pumps "due to faulty occlusion alarms."
It said the alarms "may sound when no occlusion exists, causing the pump to stop the delivery of medications" which the FDA said "may be life-threatening or may lead to death" if a high-risk drug isn't given properly.
"The FDA has identified this as a Class I recall, the most serious type of recall," the organization said in a news release at the time.
At the time, the FDA said there had been 51 complaints, one reported injury and one death related to the recalled product.
A Shared Health memo in September 2023 says Manitoba has a significant number of B. Braun Infusomat Space large volume pumps at sites and programs across the province.
The document said supply chain management got a supply of replacement pumps with serial numbers that aren't affected by faulty sensors.
Manitoba isn't the only jurisdiction using the pumps but use elsewhere appears to be limited.
That's based on CBC News asking other Canadian provinces if they use the devices. Six responded.
New Brunswick, Ontario, Saskatchewan, and Alberta said they don't use the recalled pumps while British Columbia said only a very small number were used. Nova Scotia uses a small number and hasn't had any issues in the last two years of using them.
B. Braun said it investigates and monitors concerns like the ones raised in Manitoba.