|
Model Number PMX110 |
Device Problems
Misconnection (1399); Device Contamination with Body Fluid (2317); Device Handling Problem (3265)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/02/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient was undergoing a thrombectomy procedure in the common iliac artery using a penumbra system aspiration pump max 110 (pump max).During the procedure, the hospital staff inadvertently connected the aspiration tubing (tubing) directly to the pump max rather than to the canister.Consequently, blood was aspirated into the pump max.Therefore, the pump max was removed.The procedure was completed using a penumbra engine (engine).There was no report of an adverse effect to the patient.
|
|
Search Alerts/Recalls
|
|
|