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Device Problem
Device Alarm System (1012)
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Patient Problem
Fatigue (1849)
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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.No information has been provided to date.
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Event Description
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It was reported that the patient had 3 cassettes with which had encountered a high pressure alarm while using the pump.The patient's felt that they have not been feeling well, more fatigued and the onset of these symptoms are unknown.The outcome of the events was resolved.
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Manufacturer Narrative
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Other, other text: additional information received.Patient initials, age, date of birth and sex were updated.Date of event is unknown.Unknown how many cassettes were affected.
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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 device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
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Search Alerts/Recalls
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