|
Model Number ASU1201 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device history record for the above lot has been reviewed for conformance to the cardinal health specifications.The product is tested 100% for leaks.Specifically the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.There has been no other complaint from this lot.The product dhr conforms to cardinal health specifications.Testing had been performed prior to final packaging and sterilization and met all requirements.Follow up report will be submitted once investigation has been completed.
|
|
Event Description
|
Hepatectomy in laparoscopy procedure.Hydroline probes tested prior to be use and were reported to be functional, but after few pressures the valve became defective.3 different probes used on the same patient.The suction piston has been completely blocked 3 times in a row with 3 different devices during an intervention.
|
|
Manufacturer Narrative
|
We are unable to confirm the issue reported.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on (b)(6) 2018.
|
|
Search Alerts/Recalls
|
|
|