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Catalog Number 2C9960KP |
Device Problem
No Flow (2991)
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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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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It as reported that the two (2) large volume multirate infusors did not infuse the medicine.The device did not purge, nor did it perform forced purging with three-way valves and a syringe.The issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Correction b5: change quantity to one (1), previously reported as two (2) devices.H4: the device was manufactured from june 30, 2022 ¿ july 1, 2022.H10: the device was received for evaluation.A visual inspection with the naked eye was performed which did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the results were found to be within the product specification range.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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