Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Udi and catalog information are unknown.Premarket (510k) number is unknown.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 reported that she had a defective cassette so she had to change early.Patient did not use any from her emergency kit and didn't need any durable medical supplies for now.Patient denied consult.No further information available or dates are known or were reported.All known information is contained on this form.Any additional information will be provided on a separate report.No additional information, details or dates are available at this time.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.The reported product fault occur while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.Actual cassette available for investigation.It was unknown if the cassette was replaced.Patient had additional cassettes to switch to.The infusion was life sustaining.The outcome of the event was resolved.Reported to (b)(6) by patient/ caregiver.
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Manufacturer Narrative
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Event problem and evaluation codes: updates not required.
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Event Description
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Additional information received on (b)(6) 2022 via email and attached to complaint object: unknown what pump was used since the report was filed for cassette only.It was also stated that they will reach out to their pharmacy partners to confirm with patient and update us once response was available.Patient details updated below.
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Manufacturer Narrative
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No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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