Catalog Number 114158 (A1100) |
Device Problem
Defective Alarm (1014)
|
Patient Problem
Blood Loss (2597)
|
Event Date 09/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device returned for investigation.Investigation is in process.Follow-up will be submitted pending results of the investigation.
|
|
Event Description
|
It was reported that during therapy with the aquadex flexflow system, the console did not give a blood leak detected alarm.
|
|
Event Description
|
It was reported that during therapy with the aquadex flexflow system, the console did not give a blood leak detected alarm.
|
|
Manufacturer Narrative
|
Suspect device was returned for analysis.There were no signs of damage and the device was verified to be within calibration as-found.The aquadex console blood leak detector was tested as-found by simulating therapy and alarmed as designed when blood samples ranging from 1%-29% hematocrit were passed through the detector.An in-house control console blood leak detector was used to confirm the analysis.Analysis of the device was unable to confirm the reported condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported event could not be determined.
|
|
Search Alerts/Recalls
|