ERIKA DE REYNOSA, S.A. DE C.V. CLIC BLOOD CHAMBER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
|
Back to Search Results |
|
Model Number CL10041021 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
|
|
Event Description
|
It was reported that a clic blood chamber leaked blood during a patient¿s hemodialysis (hd) treatment.The leak was reportedly coming from ¿the juncture of the smooth blue section and the square blue/white section¿.The sample was discarded due to concerns over blood exposure.It is unknown how much blood loss there was as a result of the reported event.Multiple attempts were made to obtain additional, and thus far, no further details have been provided.
|
|
Search Alerts/Recalls
|
|
|