TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 195240 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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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 level sensor pads would not stick.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 block: concomitant medical products.Per the manufacturer's territory manager, the pads were not mounted on a seam and the user facility waited to the recommended five minutes before attaching the level sensor.
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Manufacturer Narrative
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(b)(4).The reported complaint could not be confirmed.Additional parts returned were determined to be applicable to this complaint.During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the reported issue.The mounting pads stay adhered to oxygenator throughout the three hour testing period.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This complaint is related to (b)(4)/ medwatch #1828100-2018-00068.
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Search Alerts/Recalls
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