Health Canada — Medical Devices · Canada · 2016-12-05 · Type II
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Reported risk: Change to 1 (one) page on an instruction card set that attaches to the 3860 units. IRadimed Corp continues to investigate reports of possible fluid free flow, and concluded that stretching or improper placement of the IV set during pump set up is the primary cause of these reports. In 2012, IRadimed customers received an updated quick reference instruction card which emphasized proper placement of IV set during pump set up. Since that time, newer customers did not receive this updated quick reference instruction card. Though no incidences of injury have occured, IRadimed is proactively re-issuing this notice to assure the continued safe use of MRidium MR Infusion Pump Systems.
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