Section d10, h4: correction manufacturer's investigation conclusion: the relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The reported pump stoppages were confirmed through the review of the log file submitted by the account.Based on experience with the hmii lvas and similar reported events, the pump stoppages that occurred while the patient was supported by batteries could be indicative of driveline damage.However, no damage was identified through the examination of the distal end of the patient¿s driveline.The account communicated that the patient was experiencing significant pump stoppages.The patient underwent an external driveline repair on (b)(6) 2020.Pump stops reportedly returned following the repair.Initially, an unroofing procedure was planned after which the patient was to undergo a second external driveline repair; however, additional information indicated that the account had been exercising the patient in various ways and was unable to duplicate the alarms.It was ultimately decided to get the patient¿s anticoagulation therapeutic and send him home knowing that the device could fail at any point.The account will address more alarms if they come up.The submitted log file contained data from (b)(6) 2020 through (b)(6) 2020.Multiple pump stoppage events were captured on (b)(6) 2020 while the system was supported by battery power.No other atypical alarms or events were noted.The pump maintained a speed above the low speed limit for the remainder of the log file and appeared to be functioning as intended.Approximately 23.0" of the driveline, s/n (b)(6), was returned for evaluation.Of note, the majority of the silicone jacket was sliced open lengthwise.The metal connector pins and bend relief were unremarkable.An electrical continuity test of the returned portion of the driveline was conducted and all wires were found to be electrically intact.No wire-to-wire or wire-to-shield shorts were induced during this testing.The clear bionate layer was in good condition with no signs of damage.Breakdown of the metal braided shield was observed approximately 2.5¿ from the metal connector.Visual and microscopic inspection of the underlying wires found them to be unremarkable.The driveline was then submerged in a saline solution for hi-pot testing to check for current leakage through the wire insulation, and no areas of compromised wire insulation were identified.There was also an incidental finding of minor wear of the green dash alignment indicator on the metal connector.The hmii lvas ifu and patient handbook explain that all hm ii lvas drivelines have the potential for wire/shield breakdown to occur dependent on length of use and movement/flexing over time.Information regarding driveline care can also be found in both of these documents.The current heartmate ii lvas, discusses pump speed, power, flow, and pulsatility index in section 1, ¿introduction¿.This ifu also outlines the indications of driveline damage, as well as how to respond to such events.The section entitled ¿alarms and troubleshooting¿ contains information regarding alarms on the system controller, including the low speed advisory/hazard and pump off alarms, and the proper actions associated with them.The user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damaged).Section 8 "equipment storage and care" of the heartmate ii lvas ifu and section 6 "caring for the equipment" of the heartmate ii patient handbook provide instructions for cleaning the lvas equipment and provide a list of cleaning agents that can be used.The current heartmate ii lvas patient handbook, contains a section on ¿caring for the driveline¿, however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.The section entitled ¿alarms and troubleshooting¿ contains information regarding alarms on the system controller, including the low speed advisory/hazard and pump off alarms, and the proper actions associated with them.In the event of a red heart/pump off alarm, the user is instructed to connect to a working power source right away and if connecting to power does not resolve the alarm, press any button on the system controller to attempt pump start and call your hospital contact immediately.The patient handbook also provides instructions in the event the pump stops in section 8 ¿handling emergencies¿.No further information was provided.The manufacturer is closing the file on this event.
|