Originally published by our sister publication Specialty Pharmacy Continuum
By SPC Staff
The FDA posted an alert noting that Fresenius Kabi USA has issued a letter to healthcare providers regarding a potentially high-risk infusion pump software issue. 
The letter recommended that customers update the Large Volume Pump software, version 5.9.2 and earlier, for its Ivenix Infusion System to version 5.10. The FDA said it is monitoring the issue and will provide updates as new information becomes available.
“These anomalies have the potential to cause serious patient harm or death,” the FDA noted. Underdosing may lead to temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes. Over-infusion, meanwhile, may cause hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation.
Fresenius Kabi USA has not reported any injuries or deaths associated with the software issues, which include the following:
• If the pause audio option is repeated 70 times or more during an alarm condition, the pump will become nonfunctional, which in turn may cause the patient to be underdosed or have their therapy delayed.
• If a primary infusion completes and a second infusion begins at the same moment, the pump will switch to primary once the secondary infusion completes. The primary infusion will then proceed at the previously programmed primary rate, which could lead to the patient being over-infused.
The FDA alert is part of the agency’s Communications Pilot to Enhance the Medical Device Recall Program.