Device Problem
Inaccurate Delivery (2339)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 04/01/2023 |
Event Type
malfunction
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Event Description
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It was reported while using the disposable extension set the patient is new to remodulin this admission and are getting severe hypotension requiring pressors to support them.They have their remodulin doses titrated down and weaned off pressors.To resolve symptoms, required treatment included added pressors, moved to icu, profound hypertension (symptoms are not uncommon, but are not this severe.
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No serial/lot number was provided; therefore, a device history record (dhr) review could not be conducted.
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Manufacturer Narrative
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The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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