Model Number 8300 |
Device Problems
Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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It was reported there was an infusion error.No additional information.No patient involvement.
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Manufacturer Narrative
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The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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It was reported there was an infusion error.No additional information.No patient involvement.
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Event Description
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It was reported there was an infusion error.No additional information.No patient involvement.
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Manufacturer Narrative
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A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.Based on the findings, service determined that the probable root cause of the reported issue was due to electrical failure of the oridion board communication failure.A review of the device history record showed the device had a manufacture date of 09jul2019.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
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Search Alerts/Recalls
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