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Catalog Number H938724 |
Device Problems
Filling Problem (1233); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 during compounding with an em2400 valve set, the compounder alerted an error message stating that the bag was greater than 15%.The pharmacist attempted to re-prime, recalibrate, and adjust the scale; however, it is was not resolved.There were no observed defects with the set.The valve set was replaced.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured from march 11, 2022 to march 15, 2022.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed and no calibration issue was observed.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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