LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 60-00-60Z |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in dallas, texas.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The unit had two flow modules and both were set to "dev1".All flow modules are shipped pre-programmed with being device 2.The customer wanted 2 flow modules on a unit, therefore one of them needed to be renamed to device 2 in order that it had its own label for recognition.To solve the issue and to have a flow dev 1 and flow dev2, s5 system firmware was flashed to a new version.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova deutschland received a report that a centrifugal pump 5 (cp5) was displaying an incorrect flow (flow measuring issue) during procedure.There was no patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: through follow-up communication, livanova learned that the customer holds 1cp5 system that is composed by default by: 1 control panel, 1 drive unit, 1 flow sensor and , 1 flow module as per device instructions for use.In addition, the customer got an additional spare flow module.Therefore, the two flow modules were not in the same system when they were installed.This is an off label use, since it was solely caused by a user error who installed inside the e/p (electronics and power) pack two flow modules even if the system was not configured to accept two cp5 units and so two flow modules.No patient impact and no specific trend.The event has been re-assessed as not reportable.
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