The MHRA, the Government body responsible for regulating medical devices, has issued a medical safety alert that Smiths Medical manufactured CADD administration sets with Flow Stop free-flow protection are at risk of under-infusing and may display an error that infusions have not been completed. The MHRA safety alert requires healthcare providers to assess the risks and benefits associated with the use of the system, where accuracy of administering therapies is critical, on all devices with an expiration date on or before 31 March 2021 before these are used.
The system includes the insulin pump and diabetes manager used to administer medication to patients, including diabetics. It is reported that the pump may display an error message “M83 pump not able to complete task” but may still complete the infusion. There is a risk that users administering medication may repeat the programmed task, thus administering two doses of medication to the patient. The pump’s history will reveal whether an infusion has been completed and users are instructed to check whether the programmed task was completed when an error message is shown.
Roche issued a field safety notice for the CADD system in March 2016 but there was a poor level of acknowledgement that healthcare professionals and users had received and acted on instructions.
Arran Macleod, a clinical negligence lawyer at Penningtons Manches, commented: “It is important that this medical safety alert is actioned and all healthcare professionals using the affected system know of the potential problems with the device. Administering enhanced levels of medication may have adverse effects on a patient and cause them to suffer short and/or long-term injuries.”