|
Catalog Number H938724 |
Device Problems
Filling Problem (1233); Protective Measures Problem (3015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/19/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
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.
|
|
Manufacturer Narrative
|
H4: the lot was manufactured from march 11, 2022 to march 15, 2022.H10: 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 discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|