Smiths Medical has recalled infusion systems used by thousands of patients to administer potentially life-saving medication. According to the recall, CADD infusion system administration sets and cassette reservoirs were issued a Class I recall, the most serious of recalls, because tube blockages and faulty alarms have resulted in patients receiving too little or too much medication.
This classification is given when faults within a product can result in serious injury, or even death. In the case of Smiths Medical, thousands of incidents of malfunctioning equipment were reported to the FDA.
The recalled products had two main malfunctions – firstly, with tube blockages, and then with the actual alarms fitted to the machines. As many as 1,571 incidents related to tubular blocking were reported, including 14 injuries and two deaths. An even higher number of incidents related to false NDA (No Disposable Attached) alarms on the infusions systems were reported. These amounted to 9,101 incidents, and included 11 injuries.
“Infusion system” isn’t your garden variety English. The term sounds complicated and confusing but basically this is a special machine which helps to administer medication – often life-sustaining medication – to a patient. This is not the kind of thing which can run with a glitch in its mechanics.
In the case of Smiths Medical infusion systems, faults in the machinery resulted in medicine either under- or over-delivered. For someone whose life depends on the correct dosage of medication being given, this is of grave concern.
The result: Smiths Medical issued an “Urgent Medical Device Correction Letter” to patients and clinicians advising them of the recall.
This recent incident involving the Class I recall was not the first time Smiths Medical made headlines. In November 2021, the same company was issued with a warning letter by the FDA for numerous offences, says reports. These included lax Corrective And Preventative Actions (CAPA) procedures, mishandling of complaints, insufficient validation processes and inadequate processes for handling Medical Device Reports.
One of the complaints on the warning letter was that the company allegedly didn’t respond appropriately to complaints that its Medfusion Syringe Pump malfunctioned after unexpected battery depletions while still in use.
If you or a loved one was injured or died as a result of a faulty medication infusion system, we can help. We hold corporations accountable for profiting from poorly designed or poorly tested products. Call OnderLaw at 800-RxWatch (800-799-2824).