Dive Brief:
- FDA reported Friday that certain infusion pump systems recalled by BD on Feb. 4 have to date resulted in 55 injuries and one death. In the U.S., 774,000 devices were recalled due to software and system errors.
- According to FDA, those errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), as well as faster than expected delivery of medication (over-infusion).
- The company is working on a remediation plan required by FDA and lowered 2020 revenue and earnings guidance last month.
Dive Insight:
The medtech giant is continuing to deal with problems with its Alaris infusion pump system and modules, which the company said is used in the care of 70% of patients undergoing infusion therapy.
"Without the software update, the devices may remain vulnerable to the potential risk of multiple system and software errors," states the FDA's recall notice, labeling it a Class I event, its most serious.
On Feb. 6, BD made a last-minute decision to lower 2020 revenue and earnings guidance after the FDA directed the company to submit a comprehensive 510(k) package covering software changes.
At that time, BD said it was working with the regulatory agency on its software remediation plan for the Alaris system, which would require additional filings beyond what the company had anticipated. BD's plan is to submit its comprehensive regulatory filing in the fourth quarter of fiscal year 2020.
"As we look ahead to the balance of the fiscal year, we are focused on the resolution of the Alaris pump matter," said BD CEO Tom Polen in last month's guidance for 2020. "We stand behind the safety of the Alaris System ... Now, we need to take the necessary steps to meet the FDA's expectations with respect to the Alaris System."
Until FDA OKs its changes, BD does not plan to make new pump sales or deploy software upgrades in the field, except potentially some that are deemed medically necessary.
