Catalog Number 109990 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Cardiac Arrest (1762)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that during continuous renal replacement therapy with a prismaflex control unit and a prismaflex set, a patient coded and subsequently died.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.
|
|
Manufacturer Narrative
|
Correction: removal of information in section f related to importer - the initial report inadvertently included information in f7: report type and f7: follow - up #.This information is being removed as this mdr is a manufacturer mdr (and not an importer mdr).Should additional relevant information become available, a supplemental report will be submitted.
|
|
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.
|
|
Manufacturer Narrative
|
Correction: b1 and h1.Based on the additional information received, the prismaflex set was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|