A voluntary safety recall of widely used Alaris infusion pumps has several health systems in Michigan and others nationally scrambling to replace or repair them or educate providers how to use the problematic Becton Dickinson-made devices.
A malfunctioning infusion pump can be a big problem. Infusion pumps deliver intravenous medications, antibiotics, pain and oncology drugs and blood to patients every day. The results can be fatal if delivered too quickly or ineffective if delivered too slowly. Health care facilities and hospitals use the device for adults, children and infants.
Crain's contacted five health systems, including Southfield-based Beaumont Health and Detroit-based Henry Ford Health System, that use the Franklin, N.J.-based Becton Dickinson devices in Michigan and none report patient injuries. Defective or malfunctioning infusion pumps have been found and removed from service, officials said.
Officials from Beaumont and Henry Ford said they are not replacing the flawed Becton Dickinson Alaris infusion pumps, but are closely monitoring for malfunctions.
Michigan Medicine and its hospitals in Ann Arbor also use the Alaris infusion pump system. A spokesperson said the university hasn't made a final decision on whether to replace up to 7,000 pump component pieces cited in the recalls, but is monitoring performance for defects.
Novi-based Trinity Health is replacing all BD pumps at its 98 hospitals nationally and Munson Healthcare in Traverse City is replacing half of its 3,500 BD pumps by the end of the year, officials said.
Rick Palmer, Munson's manager of clinical engineering, said nine-hospital Munson hasn't decided which infusion pump system to purchase as replacements. He said there are other good alternatives, but Becton Dickinson controls about 80 percent of the infusion pump market.
Other companies that manufacture infusion pumps are Baxter, Johnson & Johnson, B. Braun, ICU Medical, Coviden and Hospira. The pumps range in cost from $1,000 to more than $3,000, depending on the size and use.
"We need the pumps. With COVID-19 going on, many hospital systems have recognized they don't have enough pumps," Palmer said.
Other health systems in Michigan use different infusion pump systems, including Spectrum Health (Baxter) and McLaren Health Care Corp. (B. Braun).
Since February, when Becton Dickinson announced its first voluntary recall affecting several models, the FDA has labeled three recalls on multiple models as a Class 1 voluntary recall, which is the agency's most serious type of recall, signifying the device could cause serious injury or death. Another recall, affecting other models, was labeled Class 2, which either can cause temporary harm to patients but is medically reversible or the adverse health consequence is remote.
In August alone, Becton Dickinson infusion pump users reported more than 1,100 incidents to the FDA related to the infusion pumps. At the time of the recall notice in February, the FDA had tracked 55 reported injuries and one death.
According to the FDA, a variety of Alaris infusion pump models in the series 8000 included in the recall from 2004 to 2019 — affecting 774,000 units sold in the U.S. — have produced errors that may lead to interruption of infusion, delay in infusion, slower medication delivery (under-infusion) and faster medication delivery (over-infusion).
But the problem goes back to last year when some hospital nurses at OSF St. Francis Medical Center in Peoria, Ill., began noticing problems with incorrect medication delivery times with the infusion pumps and reported it to Becton Dickinson, which investigated the problem and initiated a recall on another class of pumps, said Joseph Spallina, a health care consultant familiar with the devices with Ann Arbor-based Arvina Group LLC.
In multiple alerts and recall notices since Feb. 4, Becton Dickinson told BD Alaris customers that at least 13 infusion pump models have a variety of software and hardware problems, including damaged inter-unit interfaces, broken pump module elements and improperly secured PC unit battery, the company said.
In a statement, a Becton Dickinson spokesman told Crain's: "We have issued voluntary recalls for the BD Alaris System, but a recall doesn't necessarily mean that devices have to be returned or stop being used."
Becton Dickinson told customers that the company has assessed the potential risks associated with using the pumps and concluded the devices can be used "in accordance with the ... user manual and the updated instructions associated with the recall communications."
Spallina said Becton Dickinson has released conflicting information about the recall. He said the FDA labeled the majority of BD devices as having serious problems. He said all the infusion pumps in the Class 1 recalls should be destroyed.
But Spallina said BD's instructions left it up to health care organizations to choose either to discard the defective devices or use them with software updates and guidance on nurse training.
"For some (hospitals), it first could be a financial issue (to not replace the pumps) and then a quality issue," Spallina said. "This is a very serious recall, no doubt about it. The facts are the FDA said using these devices can cause serious injury or death to patients."
In one recall notice to customers, Becton Dickinson said: "High risk patient populations who are receiving life sustaining infusions are at the greatest risk of harm. For these patients, stopping or significantly lowering the infusion rate can lead to serious injury or death."