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It was reported that the hls set became dislodged from the cardiohelp and the perfusionist was not able to reconnect the disposable to the cardiohelp device.The disposable was transferred to a hand crank and the patients flow was supported.An additional cardiohelp and disposable were primed and connected to the patient.The failure occurred during treatment.The patient had a cardiac arrest and did not expired.The disposable as well as the cardiohelp are in quarantine and the customer reports that this will be filed with the fda as an sre (fda report number 1402760000-2023-8008).The affected cardiohelp device will be investigated in complaint# (b)(4) (mfg report number 8010762-2023-00351).Trinity health care has a policy that states that the vendor service cannot touch the device (in question) while being checked out.Therefore a getinge field service technician (fst) had to instruct the customer (perfusionist) to do all the hands on dated on 2023-08-01.The hls release was checked if there are any body fluids or liquids and the latch was found to be working to specification.Furthermore it was simulated what happened by decoupling the hls intentionally, but left it close enough to still get the magnets to do their job.A visual alarm "disposable disconnected" appeared and if the protocol was followed on the event date which is turning the flow all the way down and than increasing that it worked correctly.When the hls set was disconnected the device went into zero flow mode, which is logged in the logfiles.The affected product cannot be technically investigated as according to the customer the hospital risk team will not release the disposable to getinge.A medical review was performed by getinge medical affairs on 2023-10-06 with following conclusion: "further details were revealed after a conversation with the customer and are disclosed below as bullet points: - the patient was placed on support in the cath lab 8 hours before the event.- after placement of support in the cath lab, the patient was moved to ccu.- in an attempt to implement hypothermic protocol, the water lines of the hls set were swapped with (assumedly) another heater cooler that could cool the patient, allowing achievement of targeted hypothermia.- no damage (or malfunction) was reported by the customer upon inspection of the cardiohelp console.The hls set module latch on the drive receiver appeared to be functional.- the hls set module was also examined by the customer and showed no damage.It is assumed this was intended to mean no damage to the three point engagement tabs located at the 9:00, 3:00, and 6:00 o¿clock positions on the hls set module as the customer stated the hls module could be reengaged with cardiohelp drive.In conversation with the customer, the following possible root causes of the event were proposed by the customer: - the hls set module was not seated properly in the pump drive at the time of original preparation.- the latch for the hls module was not properly engaged with the hls module at the time of the original connection of the hls module to the cardiohelp pump receiver/ well.- when the message ¿disposable error ¿ stop¿ was elicited by the cardiohelp console at the time the hls module was dislodged from the cardiohelp pump, the user may not have turned the rpm knob fully counterclockwise to reset the error after the cardiohelp module was replaced on the cardiohelp drive.Proposed customer root cause 1 (crc1): the hls set module was not seated properly in the pump drive at the time of original preparation.The service and user pools suggest the hls set module was properly seated on the cardiohelp drive at the time of power up.The logfiles shows a power-on event of the cardiohelp system on 18 july 2023 at 21:32:49 with the boot up sequence completing successfully.After the self check of the cardiohelp software, the user proceeded to operate the machine without event.It is assumed that extracorporeal support started at 21:41:44 on 18 july 2023.If the hls module was not properly seated in the cardiohelp pump drive, a pump disposable error ¿ stop message would have displayed when the rpm was increased beyond zero.The service pool shows no such message/error through the start of support.Therefore, the proposed crc1 is doubtful given the evidence from the service and user pool data.Proposed customer root cause 2 (crc2): the latch for the hls module was not properly engaged with the hls module at the time of the original connection of the hls module to the cardiohelp pump receiver/ well.Crc2 is feasible if the hls module was not turned completely in the counterclockwise direction to engage the latching disposable lock.When turning the hls module counterclockwise, an audibly distinct click is elicited when the latch is properly locked to the hls disposable.The instruction for use shows the process of attaching the hls module.Failure to completely engage the latch-lock mechanism may allow for dislodgment of the hls disposable during use.Crc2 is a possible root cause (as proposed) for the initial dislodgement of the disposable from the cardiohelp pump drive (19 july 2023, 05:30:22 hrs).One possible root cause of disposable dislodgement is the latching lock was inadvertently opened during waterline exchange, allowing the hls module to become dislodged when disconnecting and reconnecting the water lines.Customer proposed root cause 3 (crc3): when the message ¿pump disposable error ¿ stop¿ was elicited by the cardiohelp console at the time the hls module was dislodged from the cardiohelp pump, the user may not have turned the rpm knob fully counterclockwise to reset the error after the cardiohelp module was replaced on the cardiohelp drive.The product ifu lists a pump disposable error ¿ stop as high priority error.The recommended action is [proper] placement of the hls disposable in the cardiohelp drive.To reengage the cardiohelp pump with the disposable after a pump disposable error ¿ stop message, the rpm knob must be turned counterclockwise to reset the target speed, then the desired target speed may be redeclared to resume with the intended flow.Therefore, crc3 may be a plausible root cause as proposed.An examination of the logfiles shows nine (9) occasions of backflow protection (bfp) occurring immediately after issuance of the pump disposable error ¿ stop message.Bfp started at 05:30:29 and proceeded through 05:34:18 (19 jul 2023, service pool).Correspondingly, bfp was turned off by the user on nine (9) occasions from 05:30:39 to 05:34:03 in response to the initiation of bfp (19 jul 2023, user pool).The service and user pool data suggest that the arterial line was not clamped (i.E., due to the activation of bfp) at the time when flow stopped secondary to the issuance of the pump disposable error ¿ stop message.The ifu, chapter 2.2.4 "general precautionary measures during use" shows the advisory contained with the product ifu regarding the recommendation of using tubing clamps to prevent backflow through the hls circuit.At 05:32:15 (19 jul 2023, service pool, logfiles), the cardiohelp sensor cable was disconnected from the hls module.It is assumed that the sensor cable was disconnected to allow use of the e drive (hand crank), which corresponds with the customer statement that the e drive was used to reestablish flow to the patient.Further, it was explained that no issues were encountered when the hls module was connected to the e drive for support.As a note, the sensor cable serves as a communication between the hls module and the cardiohelp console.It was explained by the customer that the patient experienced cardiac arrest during the period between the pump stop and reestablishment of blood flow using the e drive.As described, the patient was stabilized shortly after blood flow was resumed using the e drive.Despite the initial complaint stating that the patient expired because of, or during the period of, no support, conversation with the customer, clarified that not only did the patient not expire during the event but expired at some time after the reported event.The time of expiration was not disclosed during dialogue with the customer.Further, the cause of expiration was cited as secondary to existing comorbidities and, therefore, not necessarily associated with the reported event per se.Indeed, the reported cardiac arrest event may have been associated with the period of no flow; however, the patient comorbidities may have also played a significant role in inducing cardiac arrest.The relevance of the patient comorbidities (in terms of either the cardiac arrest event or the expiration of the patient) was not discussed by the customer.The customer clearly stated that it was unlikely that the hls disposable would be shipped back to getinge as it was in the possession of hospital risk management and, as such, was in quarantine at the hospital.Also, due to the policy of the hospital, a getinge field service technician (fst) was unable to examine the hardware without using as a perfusionist as a service proxy.In conclusion, it is challenging to assign a direct association between the expiration of the patient and the reported event to either a malfunction or a diminution in performance to the either the cardiohelp hardware or hls set advanced.That said the period of no-flow during which the user transitioned from the cardiohelp console to the e drive may have contributed to the observed cardiac arrest.However, it is not known to what extent existing comorbidities contributed to either the arrest event or to the eventual expiration of the patient during support." the production records of the affected product were reviewed on 2023-10-18.Referring to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "disposable dislodged from console" could be confirmed, but the exact root cause remains unknown.According to the customer the cardiac arrest of the patient was not due to a device malfunction.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-07-21 till 2023-07-21).The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.Note: if significant information becomes available we will re-open the complaint and initiate necessary steps h3 other text : device not released by customer.
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