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 03/23/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The srt replaced the o2 sensor and the unit operated to manufacturer specifications and was returned to clinical use.During the laboratory evaluation, the o2 sensor accuracy was not within specifications during initial testing after calibration but a second calibration after 20 minutes brought the o2 sensor within specifications.The product surveillance technician (pst) removed the o2 sensor from the bag it came in and let it set vertically for 15 minutes outside of an epgs.After the 15 minutes, he installed the o2 sensor into a lab-use only (luo) epgs.The pst connected the luo epgs to a system-1 simulator and central control monitor (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 1.99 volts (v) which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% accurracy which did not meet specifications with flow set at 5 l/min as shown in the table below: (b)(6).
|
|
Event Description
|
Upon receipt of the device, the service repair technician (srt) reported that the oxygen (o2) sensor failed during phase 2 testing on the electronic patient gas system (epgs).The o2 sensor reading was 80.3% and servomex reading 76.0%, and acceptable result is +/- 3% per specifications.This is considered an "out of box" failure.There was no patient involvement.
|
|
Manufacturer Narrative
|
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
|
|
|