Model Number 21-7302-24 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.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 that the patient was infused with a recall affected lot numbered medication cassette.Patient experienced lightheadedness which they are unsure if it was due to the cassette or hospitalization.
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Manufacturer Narrative
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Corrected data: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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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.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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Search Alerts/Recalls
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