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Catalog Number 2C1008K |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a large volume infusor underinfused medication to the patient.After the expected therapy time was completed, residual medication remained within the device that had not been delivered to the patient.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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H4: device manufacture date ¿ the lot was manufactured between march 23-27, 2023.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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