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 Consequences Or Impact To Patient (2199)
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Event Date 08/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's subsidiary, the battery icon color on the central control monitor (ccm) and the light emitting diode (led) on the front panel of the heart-lung machine (hlm) were both green.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the system would not switch from alternating current (ac) to battery power.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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Updated blocks: h3 and h6.The reported complaint was not verifiable.Diligence attempts for part return were unsuccessful so an evaluation could not be completed.Per manufacturer's subsidiary, the service data card was an old type and log files could not be downloaded.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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