Catalog Number 4711500396-1 |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/13/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source, foreign - event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.Investigation results concluded that the product is conform and the root cause is undetermined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It has been reported that during preparation of the system, the fluid wasn't released from the pouch.To move forward with the procedure a second system was prepared and functioned accordingly.
|
|
Event Description
|
It has been reported that during preparation of the system, the fluid wasn't released from the pouch.To move forward with the procedure a second system was prepared and functioned accordingly.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|