TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
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Model Number 801041 |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per the user facility, this error message has occurred three times but are unsure of specific dates.
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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, there was a belt slip error message displayed.As a result, an alternative 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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Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the main bearing to be leaking grease on the encoder wheel and drive belt area of pump causing the belt to slip.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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