TERUMO CARDIOVASCULAR SYSTEMS CORP. 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
Fluid/Blood Leak (1250)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Evaluation is in progress, but not yet concluded.Per the srt, the battery will need to be replaced in the bpm unit.
|
|
Event Description
|
The service repair technician (srt) reported that during routine testing of the device at the service center, the 12 volt (v) battery was leaking in the blood parameter monitor (bpm) unit.There was no patient involvement.
|
|
Manufacturer Narrative
|
The reported complaint was confirmed by the service repair technician observation.The battery was replaced.The device was brought to manufacturer's specifications and was returned to clinical use.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
|
|
|