Model Number 21-7608-24 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Customer did not provide the lot number of the affected device.
|
|
Event Description
|
Information was received regarding a cadd extension set.It was reported that immediately after starting to use the product, the customer noticed medical fluid was leaking from the medication cassette.There was no patient injuries noted.
|
|
Manufacturer Narrative
|
Other, other text: a photo of the device was received for evaluation.During the evaluation the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
|
|
Search Alerts/Recalls
|