Model Number 102956 |
Device Problem
Decreased Pump Speed (1500)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
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Event Description
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It was reported on (b)(6) 2024 that rpms went down to zero on (b)(6)2024 then went back up.The screen showed "set pump speed not reached", and that was stated to have happened a total of (b)(4) times.The first event happened at 10:59am.It was noted that the patient was stable.The event happened on the right ventricular assist device (rvad) side.It was stated that the last circuit exchange was (b)(6) 2024.No vital sign changes were noted during the event.
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
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Event Description
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It was reported that there was no change to the patient care or any significant events leading up to the circuit exchange.Patient plan of care was to continue to support the patient in current mechanical circulatory support (mcs) configuration until a heart would become available for transplant for the patient.
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Search Alerts/Recalls
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