It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the level sensor pad is not sticking and they had a hard time getting it to stick on the reservoir.The product was switched out with another level sensor.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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During laboratory analysis, the product surveillance technician (pst) the two returned pads stayed firmly in place on an oxygenator with level sensors mounted to the pads.No ¿not attached¿ alarms occurred while the level sensors were mounted to the oxygenator and connected to a level detect module.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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