Smiths Medical is recalling certain computerized ambulatory delivery device (CADD) administration sets and medication cassette reservoirs—both of which are intended for use with CADD infusion pumps—for two potential issues.
These issues are:
- A tubing occlusion which prevents delivery or causes under-delivery of medication. Manufacturing variations may cause the green CADD Flow Stop arm to compress and partially block (occlude) the tubing before clinical use.
- A false “No Disposable Attached (NDA)” alarm preventing pump use. Manufacturing variations on certain CADD Medication Cassette Reservoirs with Flow Stop may interfere with the pump detecting a properly attached CADD cassette.
CADD ambulatory infusion systems deliver controlled amounts of medications to patients in hospital, outpatient, and home settings. The CADD Administration Sets and CADD Medication Cassette Reservoirs are disposable and intended for use with CADD infusion pumps. They deliver the medication into a patient’s vein or through other cleared routes of administration.
Either of these recall issues can cause delay of therapy, interruption of therapy, or under-delivery of medication, which all have the potential to cause serious patient harm or death.
The U.S. FDA has identified this as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Smiths Medical reports there have been 1,571 incidents, 14 injuries and two deaths related to the tubing occlusion issue and 9,101 incidents, 11 injuries, and no deaths related to the false NDA alarm issue.