The United States Food and Drug Administration recently announced the Class I recall of certain Smiths Medical Recalls CADD System Administration Sets and Cassette Reservoirs. The recalls were initiated due to the risk of serious injury or death. FDA Class I recalls is the most serious type of recall issued by the government agency.
The recalled products, the CADD Ambulatory Infusion System Administration Sets and Cassette Reservoirs were distributed starting on June 15, 2018, until present and involved nearly 20,000,000 medical devices. This recall was initiated last month.
Smiths Medical’s CADD Ambulatory Infusion systems supply controlled amounts of medicines to patients in outpatient, hospital, and home environments. The affected CADD Medication Cassette Reservoirs and CADD Administration Sets are disposable and are designed for use with Smiths Medical’s CADD infusion pumps. These devices deliver drugs intravenously or via other paths of administration.
Smiths Medical initiated the recall of certain CADD Medication Cassette Reservoirs and CADD Administration Sets due to two potential problems that could result in injury or death:
- Tubing occlusion causes an under-delivery of medication or prevents the delivery of drugs. If the tubal occlusion does not correct when connected to the infusion pump, the pump might fail to detect the occlusion, causing the non-delivery of medication or an under-delivery of drugs, although the infusion pump displays states the infusion is operating correctly.
- A False “No Disposable Attached (NDA)” alarm stops the pump from functioning. Certain “CADD Medication Cassette Reservoirs with Flow Stop” can interrupt the pump’s detection of a properly attached CADD Medication Cassette. In some cases, the pump will sound an audible alert. Should the audible alert is not fixed within two minutes, the NDA alarm will sound. The alarm must be cleared and resolved before using the pump. A delay or interruption of therapy can occur, leading to injury or death.
Both of these issues can lead to delay of therapy, under-delivery of medication, or interruption of therapy and have the potential to cause severe injury or death. Smiths Medical has reported that they are aware of more than 1,500 adverse incidents, 14 injuries, and two deaths connected with the tubing occlusion issue, and more than 9,000 adverse incidents and 11 injuries associated with the false NDA alarm issue.
Patients who are treated with a recalled CADD infusion system with Medication Cassette Reservoirs or CADD Administration Sets could be affected by this recall. Health care professionals providing therapy using the CADD infusion system with Medication Cassette Reservoirs or CADD Administration Sets are also affected by this recall.
Smiths Medical sent an Urgent Medical Device Correction letter on December 9, 2022, to customers providing the following urgent recommendations:
For both recalls:
- Use a non-recalled model of CADD infusion sets, including those recommended for life-sustaining drugs. Contact Smiths Medical customer service to receive alternate CADD infusion sets.
For the tubing occlusion issue:
- Actions for Pharmacists – Immediately locate all affected products in your custody and make sure these devices are removed from circulation and labeled as “recalled” and to not be used for life-sustaining medications. Pharmacists should consider switching to a different infusion set and contact Smiths Medical Global Complaint Management to report any adverse events.
- Actions for Clinicians and Patients – Use caution when using an affected CADD pump because the medication may seem to be infusing properly but might not be infusing or could be underinfusing, and the infusion pump won’t alarm. Clinicians should talk to specialty pharmacies about the availability of alternative CADD infusion sets for life-sustaining medicines. Clinicians should consider switching patients to a different pump. Always prime the infusion set using the pump and watch the fluid flow closely during the process. Should the fluid not flow correctly, if the pump takes too long to prime, or if the display shows a higher-than-expected priming volume, substitute the set or reservoir. The priming volume is listed on the packaging for each administration set. Contact a clinician and Smiths Medical Global Complaint Management to report issues concerning the medication remaining in the reservoir at the end of the infusion. Clinicians should inform homecare patients and show them to prime the set as previously mentioned.
For False “No Disposable Attached (NDA)” Alarms:
- Actions for Pharmacists – Immediately identify the recalled devices in your custody and make sure that these products are isolated and labeled as recalled, and to avoid using the devices for life-sustaining medications.
- Actions for Clinicians and Patients – Be mindful that the infusion pump could not sufficiently detect the cassette prior to use or while using during an infusion. The alarm may not be triggered. Should a pump show an NDA alarm, the user needs to reposition the CADD Medication Cassette Reservoir. The user may also need to remove the reservoir from the pump. Clinicians are advised to contact their pharmacists to discuss the availability of different CADD infusion sets for patients who need life-saving medications. Clinicians should also discuss this information with their homecare patients and teach them about these recommended actions.
To report any adverse incident events or product complaints, call Smiths Medical Global Complaint Management through their website, smiths-medical.com. Healthcare professionals and patients should report any adverse reactions or quality issues they have experienced while using these devices to MedWatch.
If you or a loved one have been harmed, or if a loved one passed away due to this recalled medical device, you or your loved one could receive monetary compensation. The time is limited to make a product injury or wrongful death claim. So, do not delay and contact Parker Waichman LLP to receive a free consultation.
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