Model Number 4415 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/30/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
As per customer, the tcm pump runs for 3-4 seconds and shuts off automatically with an alarm.
|
|
Event Description
|
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the heater cooler pump was not working.The product was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
(b)(4).The field service representative (fsr) verified that the main pump would not start up and pump not primed alarm was continually setting off.The fsr found that the pressure sensor was rusted over and was malfunctioning.He replaced the pressure sensor.The unit operated to the manufacturer's specifications.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 indicated that an alternate device was employed despite the fact that the replacement unit was leaking.Towels were placed around unit to soak up water during use.
|
|
Manufacturer Narrative
|
Corrected: describe event or problem.The information in describe event or problem of the previous submission is not relevant to this complaint, please disregard.The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Search Alerts/Recalls
|