TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS DELPHIN BASE ADAPTER WITH BATTERY; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE- SARNS CENTRIFUGAL SYSTEM
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Model Number 9490 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per fsr, the internal batteries were last replaced in 2016.There was visible corrosion at the battery connector.The battery backup was plugged into the control module and alternating current (a/c) was supplied to the batteries.The user facility always leaves the unit plugged in and charging.The a/c power connection was secure.The fsr replaced the batteries.The unit operated to the manufacturer's specifications.The suspect parts were returned to the manufacturer for further evaluation.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the battery charge indicator light was not illuminated.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed one of the two batteries returned has lost its positive terminal.The missing terminal would prevent charging and prevent charge indicator (led) from illuminating.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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