Description of Event or Problem · 1
PER INCIDENT REPORT "PATIENT SEEN IN VAD/HF CLINIC BY VAD COORDINATOR (B)(6), HF NP (B)(6), HF MD (B)(6) THE DAY PRIOR ((B)(6) 2017). HEARTWARE HVAD ALARMS HISTORY WAS REVIEWED AND FREQUENT LOW FLOW ALARMS NOTED. THE LOW FLOW ALARM LIMIT WAS ADJUSTED IN CONSULTATION WITH DR. (B)(6). NO OTHER ALARMS WERE NOTED. ALL EXTERNAL HEARTWARE HVAD COMPONENTS WERE INSPECTED AND FOUND TO HAVE NO EVIDENCE OF DAMAGE OR MALFUNCTION. NO LVAD COMPONENTS WERE EXCHANGED. THE PATIENT DENIED ANY TROUBLE OPERATING HER LVAD. POST EVENT, THE HEARTWARE HVAD CONTROLLER LOG FILES WERE SENT TO MEDTRONIC FOR ASSESSMENT. IN THE ANALYSIS, THE HEARTWARE HVAD SEEMS TO BE OPERATING APPROPRIATELY UP UNTIL A SUDDEN AND COMPLETE STOP. LAST NORMAL OPERATION RECORDED AT 21:23:36, FOLLOWED BY CONTROLLER POWER-UP EVENT AT 21:50:54, WHICH IMPLIES THE HVAD SUFFERED AN UNEXPECTED POWER FAILURE AT SOME POINT BETWEEN THESE TWO TIMES. PHYSICAL INSPECTION OF THE HVAD CONTROLLER POST-EVENT FOUND IT IN UNDAMAGED CONDITION. CONSIDERING THE PATIENT WAS FOUND WITH POWER SOURCE DISCONNECTED, USER ERROR SEEMS THE MORE LIKELY CAUSE OF THIS EVENT THAN DOES DEVICE FAILURE." MANUFACTURER WAS NOTIFIED (B)(6) 2017. APOLOGIES FOR THIS LATE REPORT. PT SEEN IN CLINIC FOR ROUTINE MCS FOLLOW-UP ON SAME DAY OF EVENT. PT STATES SHE IS HAVING NEARLY CONTINUOUS LOW FLOW EVENTS, ONLY FEELS SOB DURING ACTUAL ALARM. UPON INTERROGATION OF DEVICE, FREQUENT (SEVERAL TIMES EVERY HOUR) LOW FLOWS (1.7 - 2.5 I/M) ARE NOTED. HVAD, PROVIDER NOTIFIED. BACK UP CONTROLLER INTERROGATED, SPEED AND SETTINGS SET APPROPRIATELY.