Smiths Medical

Smiths Medical provided details of a couple of possible issues with the infusion sets that are paired with CADD (Combined Annotation Dependent Depletion), in a letter to its consumers. This was following the company’s second safety alert of the year.

CADD systems are for the continuous and automatic delivery of antibiotics, chemotherapy, and other liquids to patients. The dosage directions are pre-programmed into the system by healthcare providers. It is delivered through infusion sets that include medication cartridges and the necessary tubing to connect the patient to the pump. These infusion pumps are portable and the patients are supposed to carry them during their daily lives.

Smiths Medical mentioned two newly recognized problems with the infusion sets that could be connected to two deaths and 25 injuries as they are the vital part of the infusion pumps delivering the medicine.

One of the problems is related to manufacturing. There is a spring-loaded Flow Stop arm on the infusion sets which compresses and occludes the tubing partly before the delivery of liquid starts, and it is supposed to reopen after an infusion set or medication reservoir is attached. The problem is that some of the sets might not unblock the tubing after it is connected to the pump and it may not sense the occlusion.

In such a case, the pump either delivers less than the required fluid or does not deliver them altogether, while the display screen shows that all systems are functioning properly. Despite the cause of death for the two patients is not confirmed, Smiths Medical’s letter stated that it may be linked to the deaths as well as the injuries. The company also advised healthcare providers not to use the affected products, and the patients already using the infusion sets to switch to substitute CADD infusion sets.

The second problem has also been connected to manufacturing discrepancies. The issue is that the infusion pumps might not detect when medication reservoirs are connected properly which causes a “no disposable attached” notification and the delivery does not start. According to  Medical, if the alarm goes off incorrectly, patients should reposition and reconnect the reservoir. Sometimes the reservoirs may need to be replaced.

The company also said that if the medicine to be delivered is critical, the users should switch to a different infusion system altogether.

The CADD-Legacy pumps, the reason for the false alarms, were already planned to be discontinued as of 31st December. This problem may be linked to 11 cases of grave injuries. The company confirmed that the FDA has been informed of both problems.

The previous safety alert was regarding two models of the company’s Medfusion syringe infusion pumps. Such pumps are used to give liquids to children and babies, or adults in the ICU or operating room. It has eight different software problems that caused delayed infusions or either under-delivery or over-delivery of medicine.

FDA’s most serious label was given to that recall; Class I. The recall is for over 118,000 devices that were distributed in the States ranging between October 2004 and February 2022, nearly nineteen years.

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