It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, there was a low flow alarm while in maintain mode.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
The reported complaint was not verifiable.Per the user facility's biomedical engineer, the unit was not repaired and has been taken out of service.There will be no parts returned.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|