Device Problem
Disconnection (1171)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/10/2019 |
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 (crrt) using an unknown prismaflex set, a disconnection was observed.It was reported ¿the replacement line disconnected from the bag and air got in the circuit¿.Treatment was ended without blood restitution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
|
|
Search Alerts/Recalls
|