LIVANOVA DEUTSCHLAND GMBH MAST ROLLER PUMP 85; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number 10-88-60 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that, on february 26th, at the power up, the mast roller pump 85 was running abnormally without connecting the tube.The control panel (b) detected an internal error in the motor controller was displayed (e442).Pump was rebooted and issue resolved.Accorind to used, the same issue occurred on a previous day and error log shows "no pulse block" on february 21st.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 mast roller pump, the incident occurred in japan.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Search Alerts/Recalls
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