Catalog Number ASKU |
Device Problem
Improper Flow or Infusion (2954)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/17/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The reported product is an unknown prismaflex set.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported a patient being treated with continuous renal replacement therapy using a prismaflex control unit and an unknown type of set when air entered the pre blood pump line (pbp).The pbp line was fully loaded into the pump head and the second clamp was unclamped.The treatment was terminated with the extracorporeal blood being returned to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was not returned and the lot number is unknown; therefore, a device 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
|