Company:Smiths Medical.ASD Inc.
Date of Enforcement Report 1/20/2010
Class:ll
PRODUCT
1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010;
2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Recall # Z-0651-2010
REASON
Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its software detects a system fault during routine self-tests, the Pump stops delivery and provides visual and audible alarms – which include a flashing red indicator, a display screen backlight that oscillates between bright and dim, an alarm message on the screen display and a repeating audible sound to alert the clinician of the situation. The message, Motor Not Running or Motor Rate Error also displays on the Pump screen during these alarm message events. If a MNR/ MRE alarm message event occurs during start up or during infusion, the pump will provide a visual and audible alarms and the pump will not operate. This is likely to cause an interruption or delay in therapy for the patient. Smiths Medical is requiring its customers to return all Pumps with the Serial Numbers listed in their letters. If a MNR/ MRE alarm message event occurs during start up or during infusion, the pump will provide a visual and audible alarms and the pump will not operate.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated November 16, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,436 units
DISTRIBUTION
Nationwide, including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates
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