A manufacturer recall of specific lots of CADD infusion systems recommends against using the affected systems for life-sustaining medication including brand and generic treprostinil (Remodulin) and epoprostenol (Veletri, Flolan).

Specialty pharmacies and pulmonary hypertension clinics that use CADD infusion systems for PH medications are taking action to ensure that impacted patients receive new supplies as quickly as possible. Patients who are contacted by their specialty pharmacy or PH care team about the issues described below should follow the provided directions immediately. Even infusion systems that appear to be working normally may be under-delivering medication.

An urgent device correction letter issued by Smiths Medical, a division of ICU Medical, outlines two potential problems impacting CADD infusion systems currently in use by PH patients. Each issue impacts different infusion system lot numbers.

  1. Tubing compression leading to significant under-delivery of medication but no audible alarm.
  1. “No disposable alarm” that occurs even when the medication cassette is correctly loaded. This alarm may lead to interrupted medication and should prompt replacing of the cassette.

Because both malfunctions can lead to significant under-delivery of medication, specialty pharmacies are sending impacted patients an immediate, short-term supply of medication cassettes from unaffected lots. These new supplies should be accompanied by a phone call and a letter outlining the action steps for identifying and replacing supplies that are at risk to under-deliver medication.

Patients who receive communication from their specialty pharmacy or PH specialist about their CADD infusion system should follow the provided direction immediately. Even infusion systems that appear to be working normally may be under-delivering medication.

Patients who have any concerns about their CADD infusion system should contact their PH specialist and specialty pharmacy. To contact PHA’s treatment access program, call 301-565-3004 x749 or email Katherine Kroner.