Catalog Number 955558 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Hypovolemia (2243)
|
Event Date 11/23/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an excessive fluid removal occurred during a continuous veno-venous hemodiafiltration - citrate treatment.Using a prismax device.It was reported that ¿the terminology was confusing for the staff member, incorrect selection was chosen and drawn up.¿ the patient fluid removal (pfr) was set to 1500 ml/hour which resulted in 6-7 liters removed in 4 hours.The patient status became deteriorated.Inotropes was increased and fluid resuscitation was performed.The patient outcome was not reported.No additional information is available.
|
|
Manufacturer Narrative
|
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 not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|