Model Number 2455-0500 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/03/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter name and address: address information was not able to be obtained, therefore, nj was used as a place holder.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported while using bd alaris pump module smartsite infusion set foreign matter discolored the drip chamber.There was no report of patient impact.The following information was provided by the initial reporter: the dark drip chamber and the slight darkness of the tubing itself is something new.
|
|
Event Description
|
It was reported while using bd alaris pump module smartsite infusion set foreign matter discolored the drip chamber.There was no report of patient impact.The following information was provided by the initial reporter: the dark drip chamber and the slight darkness of the tubing itself is something new.
|
|
Manufacturer Narrative
|
H6: investigation summary a complaint of drip chamber being a brown color was received from the customer.No product or photo was returned by the customer.The customer complaint of cosmetic issues - discoloration could not be verified due to the product not being returned for failure investigation.A device history record review for model 2455-0500 lot number 20086933 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
|
|
Search Alerts/Recalls
|