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

Manitoba's crab authorization has stopped utilizing an infusion pump enactment — made by a institution whose IV pumps person been the taxable of recalls — implicit concerns astir leakage and the accrued hazard of perchance hazardous chemotherapy cause spills, according to a memo obtained by CBC News.

On Dec. 17, 2024, CancerCare Manitoba recommended assemblage crab attraction programme directors and managers halt utilizing B. Braun Cyto-Set lines successful aboriginal 2025.

"Over the past year, determination person been accrued risks and concerns brought forward," the memo said.

B. Braun signed a work statement with Shared Health successful September 2021 to proviso work transportation organizations, including CancerCare Manitoba, with ample measurement infusion pumps, IV and humor medication sets. 

The Cyto-Set lines are specifically designed to present chemotherapy drugs to patients done intravenous therapy.

Issues with the lines see challenges with deficiency of compatibility with different IV equipment, leaking and accrued hazardous spills, inconsistent proviso with predominant shortages and deficiency of standardization with different equipment, according to the CancerCare memo.

CancerCare "has been moving with [the] Shared Health Supply Chain to guarantee a creaseless modulation of merchandise from the B. Braun CytoSets to B. Braun Infusomat superior lines and the existent provincial contracted Baxter secondary lines," the memo states.

The lines, oregon tubes, are hooked up to an IV pump which delivers fluids oregon doses of medications successful a controlled mode to a patient. 

The B. Braun Cyto-Set lines being pulled by CancerCare person not been taxable to a recall.

According to Health Canada, however, definite models of an IV pump made by the aforesaid shaper person been antecedently recalled by the company.  

Recalled pumps a problem, idiosyncratic says

The CancerCare memo said B. Braun Infusomat Space ample measurement infusion pumps person been successful usage successful Manitoba for astir a twelvemonth and a half. Some models of these devices person been the taxable of recalls successful some Canada and the United States.

One front-line health-care worker, whose individuality CBC has agreed to support confidential implicit concerns their occupation could beryllium affected by speaking publicly, said unit are wasting invaluable clip to marque definite the recalled pumps enactment properly.

"It's conscionable astronomical amounts of clip and effort to infuse these drugs that traditionally we didn't adjacent see the clip it took to usage a pump oregon a line," the idiosyncratic said. "They were conscionable a instrumentality that helped america bash our job."

According to Health Canada, B. Braun Medical Inc. notified the section connected June 12, 2024, astir a callback of its Horizon and Infusomat abstraction pumps.

"Devices distributed crossed Canada, including Manitoba, were included successful the recall," Health Canada said successful an email to CBC News. "The institution reported that the backcheck valve of the instrumentality whitethorn malfunction, causing a backflow of medicine from the secondary IV into the superior IV bag. It whitethorn besides origin an inability to region aerial 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, 1 progressive a decease and 16 progressive superior wellness deterioration. Health Canada won't accidental wherever successful the state these incidents occurred, citing diligent privacy.

B. Braun fixing occupation successful caller devices

Health Canada said B. Braun is fixing the occupation with the recalled pumps to forestall immoderate issues successful aboriginal manufacturing.

Written notifications were sent to idiosyncratic customers and hospitals who person received the affected pumps.

"The notifications included circumstantial instructions for clinicians for the continued usage of the pumps, until caller unaffected sets go available," Health Canada said. "B. Braun besides specified that captious medications should not beryllium fixed done 2nd IV lines."

In an emailed statement, B. Braun told CBC News it deployed a squad of objective educators to supply enhanced merchandise grooming astatine wellness facilities successful Manitoba.

"As a result, the wellness systems successful the state that implemented the recommendations, resolved the issues successful questions," the institution said.

But the Infusomat pumps are inactive causing problems, according to immoderate aesculapian providers.

The front-line idiosyncratic who spoke confidentially said health-care unit members are struggling even with the workaround instructions shared by the company.

"We're having tons of issues arsenic acold arsenic alarms going disconnected connected the pumps, aerial successful line, downstream occlusions," the front-line idiosyncratic said. 

A downstream occlusion happens erstwhile a patient's limb is bent and the cause they're getting can't travel freely into their vein, but the idiosyncratic said mendacious alarms hap often with the pumps.

The idiosyncratic said adjacent if they travel the workaround instructions, the pump is truthful delicate that it continually alarms, preventing them from getting medicine into patients.

Health-care providers are encouraged to capable retired incidental reports erstwhile determination are issues with the pumps, they said.

The front-line idiosyncratic said concerns person been tally up the concatenation of bid wrong Manitoba's determination authorities but they consciousness not capable has been done.

"It's a instrumentality we're expected to usage to administer these drugs and the instrumentality itself is broken," the idiosyncratic said.

B. Braun said immoderate facilities inactive experiencing issues with the Infusomat Space pumps and associated medication sets, oregon lines, "have been resistant to instrumentality the solutions."

"We person offered to revisit our acquisition and grooming astatine those facilities connected a fig of occasions, including recently."

Nurses national concerned 

Manitoba Nurses Union president Darlene Jackson said they've been proceeding from members astir concerns with the Infusomat pumps and lines ever since the state started utilizing them.

"Issues with leaking, with improper valve closures," Jackson said.

She said the issues were raised done labour relations officers and workplace wellness and information committees.

Jackson said it's a hazard to person health-care workers oregon household members of patients inadvertently exposed to chemo drugs, due to the fact that they termination some crab cells and mean cells.

"These are cytotoxic drugs and they impact everyone that's successful interaction with them," Jackson said. 

Jackson said dealing with the pumps is yet different situation for nurses who are already faced with dense workloads.

"It's a changeless interest that the dose is going to beryllium incorrect. If it's leaking, however overmuch did I truly give? If I've mislaid a 4th of the fluid, however overmuch cause did the diligent get and is the attraction going to beryllium therapeutic?" said Jackson.

And erstwhile alarms spell disconnected connected the pumps, she said it's hard for nurses to cognize if it's due to the fact that the instrumentality isn't moving decently oregon due to the fact that there's an existent contented with the transportation of a drug.

"If this alarm is going disconnected and I can't spot an contented that needs to beryllium troubleshot, past your question is: tin I spot this equipment?" 

A spokesperson for Shared Health told CBC News it has engaged with "B. Braun to code end-user complaints abstracted and chiseled from the September 2023 notice, immoderate of which are related to Infusomat pumps and their accessories (CytoSet IV medication systems).

"Each alert oregon announcement prompts a process successful which Shared Health investigates each imaginable origin and explores each imaginable remedy successful bid to proceed to prioritize and support diligent information and enactment beforehand enactment staff."

B. Braun pumps recalled successful the U.S. successful 2023: FDA 

In an earlier recall, the U.S. Food and Drug Administration successful November 2023 announced B. Braun was recalling much than 10,000 Infusomat Space ample measurement pumps "due to faulty occlusion alarms." 

It said the alarms "may dependable erstwhile nary occlusion exists, causing the pump to halt the transportation of medications" which the FDA said "may beryllium life-threatening oregon whitethorn pb to death" if a high-risk cause isn't fixed properly.

"The FDA has identified this arsenic a Class I recall, the astir superior benignant of recall," the enactment said successful a quality merchandise astatine the time.

At the time, the FDA said determination had been 51 complaints, 1 reported wounded and 1 decease related to the recalled product.

A Shared Health memo successful September 2023 says Manitoba has a important fig of B. Braun Infusomat Space ample measurement pumps astatine sites and programs crossed the province.

The papers said proviso concatenation absorption got a proviso of replacement pumps with serial numbers that aren't affected by faulty sensors.

Manitoba isn't the lone jurisdiction utilizing the pumps but usage elsewhere appears to beryllium limited.

That's based connected CBC News asking different Canadian provinces if they usage the devices. Six responded.

New Brunswick, Ontario, Saskatchewan, and Alberta said they don't usage the recalled pumps portion British Columbia said lone a precise tiny fig were used. Nova Scotia uses a tiny fig and hasn't had immoderate issues successful the past 2 years of utilizing them.

B. Braun said it investigates and monitors concerns similar the ones raised successful Manitoba.  

"We support that due grooming and acquisition volition resoluteness the bulk of the issues being raised by the facilities."