Medical device manufacturer, Smiths Medical, has issued a medical device safety alert concerning its CADD-Solis Ambulatory Infusion Pumps [Model numbers: 2111, 2112, and 2120; serial number 1061043 through 1067598].
The manufacturer has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD-Solis Medication Cassette Reservoir or Administration Set "disposable" to the pump.
When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (engaged) position. To start an infusion with CADD-Solis Pump Models 2111(Grey Keypad) and 2112 (Yellow Keypad), and Model 2120 (VIP), when in Patient-Controlled Analgesia (PCA) mode, the lock must be fully engaged. CADD-Solis Pump Model 2120 will start in all other delivery modes without the Cassette/ Keypad Lock being engaged.
If the user is unable to fully engage the Cassette/ Keypad Lock, then Model 2111 and 2112, and Model 2120 in PCA mode, the keypad will be locked and the pump cannot be started. This could cause a delay in the start of an infusion or interruption in therapy if changing a disposable, while an alternative pump is obtained. A delay or interruption of delivery of pain medication may result in escalation of patient pain based on the underlying condition of the patient.
If users begin to experience resistance when locking a CADD-Solis pump or if they are unable to fully engage the Cassette/ Keypad Lock while turning the key, then they are advised to discontinue use of the pump and contact the manufacturer to arrange for repair. If they are not experiencing resistance when locking their CADD-Solis Pumps, there is no immediate need to return their pumps for repair.
According to the manufacturer, no report of serious injury or death related to this issue has received.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 May 2015