Model Number 803480 |
Device Problem
Calibration Problem (2890)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturer's clinical specialist visited on-site to address the perfusionist was having with the occluder.It was found during this time that the issue was use related and no service was required by the field service representative (fsr).
|
|
Event Description
|
It was reported that the occluder was not calibrating.No other details regarding the nature of this event were provided.
|
|
Manufacturer Narrative
|
The reported complaint was confirmed.Per the manufacturer's clinical specialist, the end user noticed that the tubing was partially occluded in the occluder when it was set at fully open.The user was unaware that this was normal, that the tubing was slightly occluded even when fully open in order to hold the tubing in place.The manufacturer's clinical team has provided further education on proper use to the user.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Event Description
|
Additional information received that the issue occurred during set-up of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Search Alerts/Recalls
|