Bladder Reservoirs

Indications, Safety, and Warnings

Indications for Use

The R-14 and R-38 Assist Reservoirs are intended for use as venous reservoirs in conjunction with oxygenators that are indicated for use for extracorporeal membrane oxygenation (ECMO) procedures.

Contraindications

This device used for any other purposes than for the indicated intended use is the responsibility of the user.

Warnings

Read all Warnings, precautions, and Instructions for Use carefully prior to use. Failure to read and follow all instructions or failure to observe all stated warnings, could cause serious injury or death to the patient.

• Only persons thoroughly trained in cardiopulmonary bypass procedures should use this device. Operation of each device requires constant supervision by qualified personnel for patient safety.
• Each device has been carefully manufactured, tested and packaged; however, the state of the art has not been developed to the point that Medtronic is able to ensure that the device will not leak, crack, or fail during use. Perfusion must be carefully and constantly monitored.
• Each device is intended for single use only. Do not reuse or resterilize. EO sterilized.
• The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do not use if the package is opened or damaged or if the device is damaged or the protective caps are not in place.
• Tubing should be attached in such a manner as to prevent kinks or restrictions that may alter blood flow.
• Secure all connections.
• Do not allow alcohol, alcohol-based fluids, anesthetic fluids (such as isoflurane), or corrosive solvents (such as acetone) to come into contact with the device as they may jeopardize the structural integrity.
• If air bubbles and/or leaks are observed during priming and/or operation, these conditions may result in air embolism to the patient and/or fluid loss. The extracorporeal circuit must be continually monitored. DO not use the device if these conditions are observed.
• All gas emboli must be cleared from the extracorporeal circuit before initiation bypass. Gas emboli are hazardous to the patient.
• This device should not be operated below the minimum blood flow rate for prolonged periods of time.
• This device should be placed in the operating position and checked for proper alignment and sensing response with the appropriate sensors and switches used.

Precautions

• Refer to package labeling for storage temperature requirements.
• Use aseptic technique in all procedures.
• A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.
• Additional warnings and precautions applicable to specific procedures can be found at appropriate places in the Instructions for Use.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.