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Model Number 19191 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Septic Shock (2068); Heart Failure (2206); Respiratory Failure (2484)
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Event Date 09/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release and sterilization records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide.Model: ent450.17845-5c-aw rev a 10/17.Changing your pod 3 / page 24: warning: to minimize the possibility of site infection, do not apply a pod without first using aseptic technique.This means to wash your hands, clean the insulin vial with an alcohol prep swab, clean the infusion site with soap and water and keep sterile materials away from any possible germs.Changing your pod 3 / page 34: warning: if an infusion site shows signs of infection; immediately remove the pod and apply a new one at a different site.Contact your healthcare provider.Treat the infection according to instructions from your healthcare provider.Living with diabetes 11 / page 117: at least once a day, use the pod¿s viewing window to inspect the infusion site.Check the site for signs of infection, such as pain, swelling, redness, discharge or heat.
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Event Description
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It was reported the patient was hospitalized for an erysipelas on an abscess on the right leg, that lead to septic shock, respiratory distress, cardiorespiratory failure and ischemic cardiomyopathy tnt context.The patient was treated with an introduction in reanimation services of an anti-biotherapy with big spectrum "tazocilline" 4grams 3 times per day intravenous associated with vasoactives amines, fast weaning (dysfunction initial vg with fevg at 25%) extubated at j72.The patient is scheduled to be discharged on (b)(6) 2019, with insulin pen treatment.The pod was worn on the leg.
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Search Alerts/Recalls
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