Catalog Number SCCS1002 |
Device Problem
Device Sensing Problem (2917)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/20/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
It was reported that the monitor freezes and powers down, which loses all data on the sensica urine output system.Occurs even when plugged.If data was present, it was erased.The device was plugged in.Users express inaccurate hourly urine output.Nurse confirmed the bag had less than 40cc and the device did not capture.No dependent loops were observed.Users report no urine output for up to 6 hours while monitoring actively in progress.Bag was emptied without monitoring.
|
|
Event Description
|
It was reported that the monitor freezes and powers down, which loses all data on the sensica urine output system.Occurs even when plugged.If data was present, it was erased.The device was plugged in.Users express inaccurate hourly urine output.Nurse confirmed the bag had less than 40cc and the device did not capture.No dependent loops were observed.Users report no urine output for up to 6 hours while monitoring actively in progress.Bag was emptied without monitoring.
|
|
Manufacturer Narrative
|
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.Per investigation presentation, log files show sensica recorded hourly uo=40ml 32% of the time, the reported event is unconfirmed, therefore dhr review is not required.The labelling risk review is not required as the reported event is unconfirmed.Corrections: d, h h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|
|
Search Alerts/Recalls
|