Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED A PUMP THAT DID NOT ALARM WHEN OCCLUDED ON PATIENT, THE STAFF MEMBER WHO WAS LOOKING AFTER THE PATIENT, STATED THAT 20-30 ML WAS ADMINISTERED WITH OUT ALARMING. SEEKING FURTHER DETAILS REGARDING INCIDENT. DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. "THE DEVICE HISTORY LOG WAS REVIEWED AND IT WAS INSUFFICIENT TO CONFIRM EVENTS DESCRIBED IN COMPLAINT. ANALYSIS OF HISTORY DATA: NO REPORTED DATE, BUT THE PERIOD FROM (B)(6) 10:08 (START INFUSION) TO 10:48 (SWITCH OFF) IS MATCHING WITH DESCRIPTION FOR TIMING AND FLOW RATE PROGRAMMING. AT START, THE PRESSURE LEVEL IS SET AT MAXIMUM VALUE OF 750 MMHG. NO RESET OF PREVIOUS VOLUME INFUSED AT START (VI = 1914 ML). INFUSION FLOW RATE @ 320 ML/H WITH VTBI OF 320 ML IS STARTED AT 10:08. NO EVENT DURING 39 MINUTES, BUT AT 10:47 AND DURING 2 MINUTES, 18 DOWNSTREAM OCCLUSION ALERTS ARE RECORDED. INFUSION STOPPED BY USER AND DEVICE SWITCH OFF AT 10:48. VOLUME INFUSED IS (2126 - 1914) = 212 ML (FOR A CALCULATED THEORETICAL VOLUME OF 213 ML, DEVIATION <1%). AFTER THIS, A NEW INFUSION, ALWAYS @320 ML/H IS STARTED FROM 11:08 DURING 20 MINUTES. NO EVENTS BETWEEN START AND KVO TRIGGER. THE ALERT (PRE-ALARM) OF DOWNSTREAM OCCLUSION IS A MEDIUM PRIORITY ALARM. IN THIS INFUSION CASE, THE ALERT HAS BEEN TRIGGERED BECAUSE PRESSURE HAD REACHED 700 MMHG (50 MMHG BELOW THE PROGRAMMED THRESHOLD OF 750 MMHG). THE ALERT (PRE-ALARM OCCLUSION) DON'T STOP INFUSION, BUT TRIGGER VISUAL AND SOUND WARNINGS FOLLOWING THE IFU SPECIFICATIONS.(SEE THE ATTACHED INVESTIGATION REPORT)" "THE REPORTED DEVICE WAS NOT RETURNED BACK TO FRANCE FOR INVESTIGATION AS REPAIRS WERE CARRIED OUT LOCALLY. THE CUSTOMER ""REPORTED A PUMP THAT DID NOT ALARM WHEN OCCLUDED ON PATIENT, THE STAFF MEMBER WHO WAS LOOKING AFTER THE PATIENT, STATED THAT 20-30 ML WAS ADMINISTERED WITH OUT ALARMING."" DURING SERVICING, NO PHYSICAL DAMAGE WAS FOUND ON THE INTERNAL COMPONENTS. THE PRESSURE TEST WAS PERFORMED AND THE UNIT ALARMED WITHIN TOLERANCE. THE INCIDENT OCCURRED ON (B)(6) 2022 AND THE DEVICE WAS DUE FOR THIRD YEARLY MAINTENANCE IN (B)(6) 2022 BUT MAINTENANCE SYMBOL DISPLAYED ON SCREEN. UPON ANALYSIS OF THE DATA EVENT, THE PUMP HAS ALARMED MANY OCCLUSION ALERTS, BUT ONLY AFTER 39 MINUTES. THEREFORE, THE REPORTED EVENT IS NOT CONFIRMED AND THE CAUSE IS VERY PROBABLY DUE TO THRESHOLD PRESSURE SET AT MAXIMUM VALUE (750 MMHG), EXTRAVASATION IS REALLY LONGER TO BE DETECTED IN THIS CASE. THIS COMPLAINT IS CONSIDERED AS NOT VALID. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED NO ACTION. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.