Model Number MZ9226 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/22/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics was not provided.
|
|
Event Description
|
It was reported that fluid leak was found at the filter while the patient was receiving critical medications.The leak was noticed as the clinician touched the tubing and the gloves got wet.The tubing was then replaced.The event occurred in children's intensive care unit (cicu).There was no patient injury.Although requested, additional information was not provided.
|
|
Manufacturer Narrative
|
Additional information provided; d.10.The customer¿s report of a leak at the filter was confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection under magnification of the micron filter observed the air vent membrane was wetted/compromised.No other obvious issue or damage was observed.Functional testing confirmed leaking from the filter vent.The root cause of the observed leak from the filter vent was not identified.
|
|
Event Description
|
It was reported that fluid leak was found at the filter while the patient was receiving critical medications.The leak was noticed as the clinician touched the tubing and the gloves got wet.The tubing was then replaced.The event occurred in children's intensive care unit (cicu).It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Although requested, additional event information was not provided.
|
|
Search Alerts/Recalls
|