Catalog Number 2400M |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that cloudy bags were compounded while using an em 2400 automated compounding device (acd).This was observed during unspecified process step.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: upon further review of this reported event, it was determined that there was no allegation against the em 2400 automated compounding device; the reported issue was not against the hardware device.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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