Model Number 7324 |
Device Problems
Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: unknown; no information has been provided to date.H4: device manufacture date unavailable.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 information becomes available.
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Event Description
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It was reported that medication remained in the reservoir after infusion.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.G2 email is: (b)(4).
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Search Alerts/Recalls
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