Baxa Repeater Pump Manual
Class 2 Device Recall Repeater Pump Date Initiated by Firm October 03, 2012 Date Posted October 25, 2012 Recall Status Terminated on February 15, 2013 Recall Number Z-0156-2013 Recall Event ID Product Classification - Product Code Product Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO.
The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Code Information Repeater Pump model #s 095, 099, and 099R. Recalling Firm/ Manufacturer Baxa Corporation 14445 Grasslands Dr Englewood CO For Additional Information Contact 303-690-4204 Manufacturer Reason for Recall The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use. FDA Determined Cause Packaging process control Action Baxa Corporation sent a 'REPEATER PUMP PRODUCT NOTICE' to all affected customers.
The letter identified the product, problem, and actions to be taken by the customers. All customers received a CD containing a copy of the correct Operator Mannual, 5300-0754. Contact Technical Support at 800-678-2292 for questions regarding this notice. Distribution Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela. Total Product Life Cycle 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see.
PINNACLE TPN Manager B. Braun Medical Inc (Bethlehem, PA) recently launched PINNACLE Total Parenteral Nutrition (TPN) Manager, which complements the company's PINNACLE TPN Management System. The product's advanced computerized physician order entry and calculating software automates calculations and streamlines the TPN compounding process from the moment an order is entered by the pharmacist to the time it is infused into the patient. Designed with the pharmacist in mind, the easyto- use Windows-based PINNACLE TPN Manager features several advanced tools such as customized patient templates and reports to help ensure rapid and smooth delivery. For added safety, the software includes Trissel's Ca/P graphical compatibility curves, which were developed in collaboration with national drug compatibility expert Lawrence Trissel, RPh, to address calcium/ phosphate compatibility in an effort to reduce potential errors. In addition, the labels can be generated with bar-coded prescriptions to eliminate the need for manual entry on the compounder and the infusion pump.
PINNACLE TPN Manager also promotes USP guidelines for compliance. The guidelines are designed to provide standards of care in sterile pharmaceutical compounding. The product improves compliance with these guidelines through customized daily checklists that require completion of standard operating procedures to ensure proper environmental checks during compounding and through the ability to monitor and track the entire TPN process. For more information, visit, or call 800- 854-6851. Heparin Sodium Injection USP Baxter Healthcare Corp (Deerfield, IL) recently introduced a drug-safety initiative intended to help reduce medication errors by creating enhanced packaging that provides additional safeguards to assist clinicians in the correct identification of critical medicines. As 1 of the top 5 high-alert medications, as designated by the Institute for Safe Medication Practices, Heparin Sodium Injection USP, a commonly used anticoagulant, is the first medication with the improved label.
Baxa Syringe Pump
The label features an increase of 20% font size, a unique color combination, and a large, red cautionary tear-off label. Heparin Sodium Injection is indicated for anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension. The product is not a catheter lock-flush solution and should not be used for lock flush. For more information, visit, or call 800-422-9837. Repeater Pump II Baxa Corp (Englewood, CO) recently launched the Repeater Pump II. The pump is designed to provide accurate delivery of pharmacy solutions into a variety of containers, without the need for calibration. The Repeater Pump II is the first no-calibration pharmacy pump and uses a fixed-volume pumping design commonly referred to as positive displacement.
The positive displacement nature of the pump eliminates the need for calibration or adjustment, providing accurate liquid delivery regardless of the source container, final container, tubing diameter, and fluid viscosity. The Repeater Pump II's touch screen also simplifies the process because it eliminates buttons and knobs that can be hard to press. For more information, visit, or call 800-567-BAXA (800-567-2292). Triesence (triamcinolone acetonide injectable suspension) Alcon Inc (Fort Worth, TX) recently received FDA approval for Triesence 40 mg/mL.
The product is a preservativefree synthetic corticosteroid. The product is indicated for the treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. The product also is indicated for visualization during vitrectomy. The initial recommended dose of Triesence for all indications except visualization is 4 mg (100 µL of 40-mg/mL suspension), with subsequent dosage as needed over the course of treatment. The recommended dose of Triesence for visualization is 1 mg to 4 mg (25- 100 µL of 40-mg/mL suspension) administered intravitreally. The product is available in a single-use, 1-mL vial containing 40 mg/mL of triamcinolone acetonide suspension. For more information, visit, or call 800-TO-ALCON (800-862-5266).
Pharmacy Times® is the #1 full-service pharmacy media resource in the industry. Founded in 1897, Pharmacy Times® reaches a network of over 1.3 million retail pharmacists. Through our print, digital and live events channels, Pharmacy Times® provides clinically based, practical and timely information for the practicing pharmacist.
Baxa Repeater Pump Owner S Manual
Features and specialized departments cover medication errors, drug interactions, patient education, pharmacy technology, disease state management, patient counseling, product news, pharmacy law and health-system pharmacy.