TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
|
Back to Search Results |
|
Model Number 801074 |
Device Problem
Out-Of-Box Failure (2311)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 02/16/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The srt installed a replacement o2 sensor and the unit passed phase 2 verification testing.The unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the product surveillance laboratory for further evaluation.During laboratory evaluation, the product surveillance technician (pst) installed the returned o2 sensor into a lab-use only (luo) epgs and connected the epgs to a system-1 simulator and ccm.He connected the epgs to o2 and air, and entered a perfusion screen on the ccm.After the 15 minute warm-up period, calibration of the o2 sensor was initiated and passed.The measurement of the direct current (d/c) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 1.77 volts which is within the specification of 0.55-2.758 volts.After initial calibration, he tested the o2 sensor at 3 set points as shown below: l/min = 5 set point = 100% ccm = 93.1% analyzer = 99.1%.L/min = 5 set point = 80% ccm = 79.5% analyzer = 85.9%.L/min = 5 set point = 30% ccm = 28.6% analyzer = 31.8%.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
|
Upon receipt of the device, the service repair technician (srt) reported that the electronic patient gas system (epgs) failed the oxygen (o2) sensor reading accuracy portion of the verification test.The blender setpoint at 30% the central control monitor (ccm) reported 29.4%, the external o2 analyzer showed the actual oxygen (o2) as 34.1%, which is out of the +/-3% specification.The voltage from the o2 sensor with 100% oxygen was 1.250 volts direct current (vdc), which is within specification.The o2 sensor is an out-of-box failure and will need to be replaced.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|