Model Number 2202-0007 |
Device Problem
Filling Problem (1233)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/21/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the bd alaris pump module infusion set experienced slow flow.The following information was provided by the initial reporter: i witnessed slow flow when a clinician was priming omegaven on iv set, but the line was successfully primed to the end with no manipulation, it was just slow.The vent was opened prematurely, before the drip chamber was filled.
|
|
Manufacturer Narrative
|
H6: investigation summary: no product or photo was returned by the customer.It was reported that they experienced slow flow when priming.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2202-0007 lot number 21085696 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16aug2021.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.H3 other text : see h10.
|
|
Event Description
|
It was reported that the bd alaris pump module infusion set experienced slow flow.The following information was provided by the initial reporter: i witnessed slow flow when a clinician was priming omegaven on iv set, but the line was successfully primed to the end with no manipulation, it was just slow.The vent was opened prematurely, before the drip chamber was filled.
|
|
Search Alerts/Recalls
|