|
Model Number 50000000 |
Device Problems
Restricted Flow rate (1248); Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
|
|
Event Description
|
It was reported that the arctic sun device was empty and would not fill at first.Ms&s instructed the nurse to disconnect the pads.Arctic sun device started to fill and then started to leak out from the bottom of machine.Technical support was able to determine if this machine was recently serviced and just sent back.They were guessing that the biomed did not add cleaning solution or fill when they received it.Ms&s instructed nurse to reach out to their biomed to drain machine, add solution and refill.In the meantime, they got the machine working.They were going to finish out therapy and then send device to biomed to be drained, cleaning solution added, and refilled.
|
|
Manufacturer Narrative
|
Per investigator evaluation, bd has determined that this mdr event is not reportable.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.
|
|
Event Description
|
It was reported that the arctic sun device was empty and would not fill at first.Ms&s instructed the nurse to disconnect the pads.Arctic sun device started to fill and then started to leak out from the bottom of machine.Technical support was able to determine if this machine was recently serviced and just sent back.They were guessing that the biomed did not add cleaning solution or fill when they received it.Ms&s instructed nurse to reach out to their biomed to drain machine, add solution and refill.In the meantime, they got the machine working.They were going to finish out therapy and then send device to biomed to be drained, cleaning solution added, and refilled.
|
|
Search Alerts/Recalls
|
|
|