Model Number 21-7106-24 |
Device Problem
Inaccurate Delivery (2339)
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Patient Problems
Fatigue (1849); Headache (1880); Insufficient Information (4580)
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Event Date 12/27/2022 |
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 a flash injection when changing the extension set.A few minutes after the pump started the patient experienced sensations related to the delivery of medication.Headache, redness on the upper body, asthenia palpations, drop in blood pressure.The symptoms passed during the night.Except fatigue which remains present for a whole day.
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Manufacturer Narrative
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Lot number updated from 4257059 to 4302549.
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Manufacturer Narrative
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Other, other text: d3, g1,2 email is: (b)(4).One device was received for evaluation.Visual inspection revealed no anomalies.Functional testing was performed and the reported issue could not be replicated or confirmed.The root cause could not be determined.No further action was taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture., corrected data: a1: patient identifier.
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Search Alerts/Recalls
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