FDA MedWatch - ThermaCor 1200 Disposable Sets by Smisson - Cartledge Biomedical:

Class I Recall - Due to Risk of Patient Contact to Aluminum

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: ThermaCor 1200 Disposable Sets by Smisson - Cartledge Biomedical: Class I Recall - Due to Risk of Patient Contact to Aluminum AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Smisson-Cartledge Biomedical is recalling their ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a part of the ThermaCor 1200 Disposable Set, the cassette, which warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to high levels of the metal. The recall is specific to the disposable cassette portion of the device, not to the full pump. Use of the affected product could cause increased exposure to aluminum ions. Exposure to high levels of aluminum ions could cause serious patient harm such as bone or muscle pain and weakness, anemia, seizures, or coma. There have been no complaints, reports of injuries, or deaths related to this device issue. For more information and specific recommendations about this recall, click on the red button "Read Recall" below. BACKGROUND: The ThermaCor 1200 Rapid Thermal Infusion System disposable sets are part of the ThermaCor 1200 Rapid Thermal Infusion System, which is used for fluid or bolus delivery. The system is made of a footswitch for hands-free fluid control, a fluid delivery device, and a single-use disposable set with supply lines that can be used with intravenous (IV) bags or surgical equipment. RECOMMENDATIONS: On February 18, 2021, Smisson-Cartledge Biomedical sent an Urgent Medical Device Correction Notification letter to all affected distributors and customers. The letter gave the following information: The use of balanced electrolyte solutions (i.e. lactated ringer's solution) should be limited to less than 6 hours.  Each ThermaCor Cassette is to be used for a maximum total fluid volume up to 25 liters or up to a maximum of 12 consecutive hours, whichever occurs first. Higher aluminum levels may occur when using lower flow rates, increased temperatures, with certain fluids, and in longer durations. It also identifies the following patient populations who are especially at risk: Neonates, infants, pregnant mothers, and the elderly Patients with poor renal function or on dialysis Evaluate the benefits and risks of using the device versus the patient condition. On March 23, 2021, Smisson-Cartledge Biomedical sent a follow up Urgent Medical Device Correction Notification letter to all affected customers. The letter gave the following information: To Customers: Remove the enclosed laminated card and lanyard from the package and insert the lanyard into the laminated card. Using the open end of the lanyard, attach the laminated card to pole clamp knob on the ThermaCor 1200 Rapid Thermal Infuser. Complete the enclosed stamped postcard and return to the address at the front of the card. Receive acknowledgement that the letter has been reviewed and understood. Include the ThermaCor 1200 Rapid Thermal Infuser Serial Number(s) of the devices on the "Acknowledgement Form" that now have the laminated card attached to the unit. Sign the card prior to mailing (or e-mailing) back to the company. No return of the product is necessary. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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