The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).
During the procedure, the hospital technologist inadvertently connected the aspiration tubing directly to the pump max.
Consequently, blood and fluid entered the pump when aspiration was initiated.
Although, blood and fluid entered the pump max, the physician was able to complete the procedure using the same pump max.
It was reported that the pump max started emitting smoke when it was turned on.
There was no report of an adverse effect to the patient.
|
Please note that the device was initially available for return; however, on 24-march-2017; additional information obtained confirmed that the hospital discarded of the device; therefore, no device evaluation could be performed.
The product was not returned for evaluation.
Without the return of the device, the root cause of the problem cannot be determined.
The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
The hospital disposed of the device.
|