FDA issues two serious patient safety alerts
The U.S. Food and Drug Administration (FDA) issued two important alerts on Thursday pertinent to patient safety. Both recalls, while serious, do not require removing any products from healthcare organizations or supply houses.
Instead, the notices were sent to advise the public on potential hazards that could lead to patient fatalities if the updated use instructions are not followed.
Update required on potentially dangerous infusion adapters
Becton Dickinson issued an alert for anyone in possession of its Alaris Systems Manager and Care Coordination Engine Infusion Adapters. A set of updated use instructions comes after reports of errors in the automated programming request (APR) feature, leading to system backlogs.
This issue can cause outdated APRs to upload, potentially resulting in incorrect infusion rates, doses or volumes, which could be fatal if the pumps are connected to a patient.
Although no injuries or deaths have been reported, the issue has been given a Class I designation by the FDA.
New use instructions correct the problem. Clinicians are to review all infusion parameters before use, in addition to remotely updating the CCE Infusion Adapter to v1.7.3. Any third-party or external management software used to monitor and control the pumps must also be disconnected.
Customers are encouraged to report any adverse events to Becton Dickinson at 888-562-6018 or SupportCenter@bd.com.
The full FDA notice can be found here.
Alert on aspiration system use after patient dies from injuries
Calyxo issued an urgent device field correction for its CVAC Aspiration System (REF Number CVC127020-1) due to a risk of serious injury to patients with thick fluid in their kidneys. If used on these patients, the device could cause excessive kidney pressure during irrigation, rupturing the organ.
Urologists are instructed to stop fluid inflow when outflow is slow or absent, in addition to halting irrigation if cloudy or thick fluid is present. A larger ureteral access sheath should also be deployed to encourage proper drainage.
The FDA is reviewing the issue, which has been associated with one death.
All healthcare providers known to be in possession of the systems have been notified about the safety changes. For questions, customers can contact Calyxo at qualitycontrol@calyxoinc.com or 833-214-3354.
The full early alert from the FDA can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.