TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 801074 |
Device Problem
Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is related to emdr #1828100-2016-00201.The srt replaced the o2 sensor with a new o2 sensor and that o2 sensor failed the o2 sensor accurracy test (refer to emdr #1828100-2016-00201).The srt installed another new o2 sensor and ran applicable verification tests.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.Nothing was observed visually that would cause failure.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 central control monitor (ccm).The pst connected the epgs to oxygen 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 1.94 volts which is within the specification of 0.55-2.758 volts.The pst tested the accuracy of o2% and found inaccuracies as shown below: (b)(6).After 20 minutes of testing, a second calibration was performed and the o2% accuracy then met specifications as shown below: (b)(6).
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Event Description
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Upon receipt of the device, the service repair technician (srt) reported that the new oxygen (o2) sensor failed o2 sensor accuracy test on the electronic patient gas system (epgs).This is considered an "out of box" failure.Per the srt, the o2 sensor will need to be replaced.There was no patient involvement.
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Manufacturer Narrative
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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.
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