Model Number 20128E |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/30/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
|
|
Event Description
|
The customer reported that at 2100 an infusion of tpn began then approximately 1200 the next day a leak occurred at the filter where there was a hole.There was no patient harm.
|
|
Manufacturer Narrative
|
Additional information provided.The customer¿s report of a leak at the filter was confirmed.Visual and microscopic inspection of the set observed that both filter vents looked to be wetted out (oversaturated), however there were no obvious damage to the set.Dried fluid residue was noted on the filter surface of the vent as well as the bottom vent.Functional testing confirmed leaking from bottom vent of the filter (termed ¿weeping out¿).The root cause was not identified.
|
|
Event Description
|
The customer reported that a tpn infusion was started at 2100, and by mid-afternoon the next day, a hole with leaking was identified at the filter of the extension set.There was no patient harm.
|
|
Manufacturer Narrative
|
Additional information provided.The customer¿s report of a leak at the filter was confirmed.Visual and microscopic inspection of the set observed that both filter vents looked to be wetted out (oversaturated), however there were no obvious damage to the set.Dried fluid residue was noted on the filter surface of the vent as well as the bottom vent.Functional testing confirmed leaking from bottom vent of the filter (termed ¿weeping out¿).The root cause was not identified.
|
|
Event Description
|
The customer reported that a tpn infusion was started at 2100, and by mid-afternoon the next day, a hole with leaking was identified at the filter of the extension set.There was no patient harm.
|
|
Search Alerts/Recalls
|