(b)(4).The service technician inspected the ice block and found it to be normal size.The unit operated according to manufacturer specifications, and the unit was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the heater cooler (tcm ii) produced ice block that is too large.The unit was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|