Model Number 106524US |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Right Ventricular Dysfunction (2054)
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Event Date 02/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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It was reported that the patient was readmitted on (b)(6) 2020 due to low flow alarms.Upon interrogation, the vc found there were approximately 13-14 alerts with low flow alarms.They started the patient on sildenafil due to moderate right ventricular dysfunction.The patient was discharged on (b)(6) 2020.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported low flow alarms could not be conclusively determined through this investigation as no log files from the time of the reported event were provided by the account.The patient was readmitted to the center on (b)(6) 2020 due to low flow alarms.The vad coordinator reported 13-14 low flow events with alarms upon device interrogation.The patient was started on sildenafil due to moderate right ventricular dysfunction and remains ongoing on heartmate 3 lvas, serial number, (b)(6).No further low flow alarms were reported until cs-137196.The heartmate 3 lvas ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and notes that changes in patient conditions can result in low flow.The ifu describes all system alarms and the recommended actions associated with them.No additional information was reported.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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