TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
|
Back to Search Results |
|
Model Number 500AVHCT |
Device Problem
Thermal Decomposition of Device (1071)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/21/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the printed circuit board assembly (pcba) to be damaged and appeared to be burnt.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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
|
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit would not power on.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Search Alerts/Recalls
|
|
|