Indications, Safety and Warnings
The Carpediem™ system is indicated for use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.
Limitations for use
Do not use the Carpediem™ system if patient treatment requires performance outside its operating and accuracy range as well as the operating limits specified in the Carpediem™ system Operator’s Manual. The Carpediem™ system allows anticoagulation method with heparin only.
Contraindications
Patients with a history of allergic reactions to polyethersulfone should not be treated using the Carpediem™ system. The choice to perform CRRT must consider the balance between risk and benefit for patients that have general contraindications to using an extracorporeal therapy. These factors include: hemodynamic instability, contraindication to suitable anticoagulation, low platelet count, lack of suitable placement for vascular access.
Warnings
Replacement fluid for hemofiltration should be prescribed by a physician and should be commercially available or prepared in the hospital pharmacy, labeled sterile and for intravenous injection. The device is intended to be used by trained clinicians who are experienced in administrating and managing continuous renal replacement therapy (CRRT) in critically ill pediatric patients.
Cautions
Read all Instructions for Use carefully prior to use. For complete details of the system, including product and important safety information such as indications, contraindications, warnings, and precautions associated with the system and its components, refer to the Carpediem™ system Operator’s Manual and the respective system component’s Instructions for Use. Rx only.
