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Device Problem
Inaccurate Delivery (2339)
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Patient Problems
Headache (1880); Nausea (1970); Pulmonary Hypertension (4460)
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Event Date 04/01/2023 |
Event Type
malfunction
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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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Event Description
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It was reported while using the disposable extension set the patient experiencing severe symptoms with the disposable exchanges.Patient experienced nausea and headache around disposable exchange time.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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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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Lot and item number have not been provided to date, d4 model number, lot number, udi number, expiration date and h4 are unavailable, corrected data: d1, d3, g2.Correction to follow-up 001, h2: device evaluation.
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Search Alerts/Recalls
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