Model Number 801763 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Power Up (1476)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Per the subsidiary, the roller pumps were able to be started but it was not possible to program the pumps to obtain the desired flows for the patient without the ccm booting up.
|
|
Event Description
|
It was reported that the central control monitor (ccm) would not turn on.No other details regarding the nature of this event were provided.
|
|
Manufacturer Narrative
|
The reported complaint was not verifiable.Multiple diligence attempts for part return and additional information were unsuccessful so an evaluation could not be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Event Description
|
Additional information was received that the reported issue occurred during priming of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.There was a five minute delay to change out the batteries.There was no blood loss nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
Per the subsidiary, when the heart lung machine (hlm) was disconnected from alternating current (a/c) power it shut down.The user facility installed new batteries that were from another manufacturer.After reconnecting the hlm, the unit was able to be used for the surgical procedure.
|
|
Search Alerts/Recalls
|