It was reported that during a change of the cleo® 90 infusion set, the patient observed bleeding at the infusion site.The patient reported that they began to notice the blood at the infusion site after their health care personnel (hcp) changed and increased their medication dosage on (b)(6).The medication was changed to mirtazapine.The blood at the infusion site had resulted in a blockage of the infusion site and blood within in the infusion set tubing.According to the report, the patient blood glucose level was 273 mg/dl at the time of the event; the patient did not have ketones.To resolve their high blood glucose levels, the patient changed their plastic cannula infusion set to a steel cannula infusion set and delivered an insulin bolus with the infusion pump.The patient reported that they did not observe any damaged when the infusion set package was first opened; however, the adhesive of the infusion set would be removed with the infusion set cap.Additionally, it was reported that the patient experienced "contact detach" with the infusion set.The patient reported that they will discuss their medication with their hcp as they believe blood thinning may be a possible side effect of the new medication and increased dosage.No permanent adverse effects to patient reported.Related mfr #'s: 3012307300-2017-00840, 3012307300-2017-00841, 3012307300-2017-00842, 3012307300-2017-00843, 3012307300-2017-00845.
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