TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 801764 |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Per the distributor, the heart lung machine (hlm) is now working fine, they had found that one of the batteries was not working properly.
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Event Description
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It was reported that during routine testing of the device, the unit was not switching over to battery in the case of alternating current (ac) power failure.There was no patient involvement.
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Manufacturer Narrative
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Per the manufacturer's subsidiary, the replaced battery was disposed of so an evaluation could not be completed.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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Search Alerts/Recalls
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