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Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.