Model Number 21-7359-24 |
Device Problems
Device Alarm System (1012); Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2023 |
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 the disposable did not deliver medication and the pump did not alarm.The patient had to use the pump for extra 24 hours to allow medication to infuse.No patient injury reported.
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Manufacturer Narrative
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Other text: patient identifiers updated.Date of event updated.
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Manufacturer Narrative
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No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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