California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps. At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August 25. The seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications.
This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected.
Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once.
If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended infusion rate.
For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If not detected during programming verification, key bounce events may result in serious patient harm or death.
FDA inspections revealed that Alaris failed to follow FDA’s medical device manufacturing regulations
FDA inspections revealed that Alaris failed to follow FDA’s medical device manufacturing regulations. The infusion pumps were seized by the U.S. Marshals Service at Alaris’ manufacturing facility in San Diego, California.
The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so.
Alaris was issued warning letters by FDA in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but failed to take appropriate actions.
In an August 15 recall letter, Alaris informed customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available.
In the letter, Alaris also provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. The steps are as follows:
When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key.
Focus on listening to the number of beeps while programming IV pumps; each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry.
Verify Screen Display
When programming the pump or changing settings, always compare the patient’s prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion.
Request an independent double check of pump settings by another practitioner
Independent Double Check
Request an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs.
Before leaving the patient’s room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected. Adjust accordingly.
Healthcare facilities can continue to use pumps in their possession, guided by these and further instructions.
For more information, check Alaris’ Web site at: http://www.cardinalhealth.com/alaris/