The safety issues prompted the FDA to issue a Class 1 Recall - the most serious type of recall, reserved for situations in which "there is a reasonable probability that use of the product will cause serious injury or death."
The Alaris line of infusion pumps are a range of electronic devices intended for the controlled delivery of intravenous, intra-arterial or epidural solutions and medications to patients. A design defect known as 'key bounce' was identified in the touch-sensitive key-pad on the Alaris (SE) pump product, resulting in the key-pad registering a number twice although the button is only pressed once.
For example, if a medication was intended to be infused at a rate of 4ml an hour, key bounce could cause the machine to register an input of 44ml - causing the pump to administer more than 10 times the intended amount of medication.
Cardinal Health initiated a voluntary action plan in August 2006, sending warning letters and labels to customers. However, two weeks later production, sales, repairs and installations of the Alaris infusion pumps were halted as the FDA seized 1,300 units (worth a total of around $1.8m) from the company's San Diego facility.
The FDA has found fault with the quality of the Alaris pump on several occasions, issuing warning letters in 1998 and 1999 which were not acted upon by the company. A more recent inspection in February 2006 revealed significant manufacturing and quality violations in the Alaris product line, and the product seizure was implemented following confirmation of the key-bounce defect to prevent the faulty goods being distributed.
The global healthcare company has now outlined a programme of steps it will take in order to resume manufacture and sales of the Alaris (SE) pumps, which must be approved by the FDA and the US District Court for the Southern District of California before the plan is implemented.
The proposals to help the product to get back on the market include submitting a plan to the FDA outlining corrections for the Alaris (SE) pumps currently in use by customers, submitting a remediation plan for the seized pumps, and engaging an independent expert to inspect Alaris (SE) pump facilities and certify Cardinal Health's operations.
The company put aside $13.5m in the first quarter 2007 to cover the estimated costs of implementing the corrective action plan.
Around 14,000 Alaris (SE) infusion pumps have been distributed by the company worldwide over the last 12 years, and the product line represents under 1 per cent of the annual revenue for the company's Clinical Technologies and Services unit.
Less than two weeks ago Cardinal Health announced the sale of its Pharmaceutical Technologies and Services (PTS) segment for a healthy $3.3bn. The decision to sell off the segment was made to focus the company's resources on products and services that serve healthcare providers such as hospitals and pharmacies.
The firm did, however, retain Martindale and Beckloff Associates, two businesses that support the generic pharmaceutical market. Martindale develops generic, intravenous medicine, and Beckloff provides regulatory consulting services, including for Cardinal Health's generic products.