LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number 10-80-00 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2024 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that, during ser up after a few seconds that the pump module is running, a s5 roller pump 150 displayed error message pump motor control fault 1 on the display.Despite several attempts to reset the pump, the message remains.There was no patient involvement.
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in italy.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H10: a complaints database review has been performed and it was determined that this complaint is a duplicate of another one, already submitted (mfr #9611109-2024-00137, livanova ref.(b)(4)).Therefore, this event will be voided.
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Event Description
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See initial report.
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