It was reported that one venous bubble alarm and two arterial bubble alarms were triggered without any visible air bubbles.The event occurred during treatment.No intervention was set for the redundant venous bubble sensor.The intervention of the mandatory arterial air bubble sensor triggered the pump stop twice as per design to prevent complications of air embolism.After each pump stop the customer manually clamped the lines, aspirated from the pre oxygenator pigtail and inspected the circuit for air.No air was seen on aspiration.The treatment was continues about 1 minute and 46 seconds after the first pump stop.The patient did die many days later, according to the customer this was not at all related to this incident.The clinic did not elaborate on the cause of death.A getinge field service technician (fst) was sent for investigation on 2022-10-27.The cardiohelp and both the venous and the arterial bubble sensors were tested and no device malfunction was identified during the service.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the log file review performed by getinge life cycle engineering for the reported date of event 2022-10-23 at 17:48:37 (cardiohelp time), the venous bubble was detected 3 seconds before the first arterial bubble alarm was logged at 17:48:37.No intervention was set by the user for the venous bubble monitoring, therefore only the arterial bubble detection stopped the pump.The operator reset at 17:49:49 the arterial bubble intervention leading to a pump start (downtime.1 min 12 sec) shortly afterwards (2 sec) a second arterial bubble alarm was logged with a downtime of 34 sec.In two triggered pump stops there was in total no flow for 1 minute and 46 seconds (1 min 12 sec and 34 sec downtime) a medical review was performed by getinge medical affairs on 2022-12-05 with the following conclusion: the review of the patient outcome and any association with this sequence of events is challenging given there is a paucity of clinical information.However, a review of the customer product complaint single report, follow-up correspondence, service report, and logs files provide reasonable insight into the most likely root cause of the event reported based on the available information.The most likely root cause of sequential air bubble alarms on both venous bubble sensor and arterial flow bubble sensor appears to be related to the administration of albumin via the central line during therapy.As described in the evaluation, a rapid change in the nature of the fluid transiting the acoustic window in an ultrasonic bubble sensor can trigger a false positive bubble.The log file alarms and the reported concurrent administration of albumin support this mechanism.The service report indicated the system and bubble sensors were functioning to specification.The clinician reported no air was visualized during the de-airing protocol.In sum, this supports the conclusion this occurrence was a ¿false positive alarm¿ triggered by the above mechanism.The safety system intervention and the observed occurrence are known limits of the technology and sensitivity of ultrasonic sensors.The transmission of air into the circuit by any means is always possible but the available information does not support this conclusion given the description provided by the end user.Although the patient outcome is very unfortunate, based on the available information and associated self-reporting by the clinic, no association between the patient outcome and this sequence of events can be suggested.The cardiohelp device and safety systems functioned within specification.The false positive alarm proposed is a known limitation of state of the art technology.A determination of whether a use error occurred is challenging.Rapid administration of fluids (colloids/crystalloids) is a common and necessary clinical intervention for patients undergoing extracorporeal support.False positive alarms can occur based on the limitations of the technology as described above.It appears that the event was expertly managed by the clinician and is consistent with best practice, training, and the device cautions and warnings in the instructions for use (gmbh, heart lung support system cardiohelp system instruction guidelines, 2022), (gmbh & maquet cardiopulmonary , hls cannulae set instructions for use |2.6 |g-139|05).According to the instruction for use chapter 5.3.1 connecting the combined flow/bubble sensor the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.The review of the non-conformities has been performed on 2022-12-05 for the period of 2020-06-24 to 2022-10-26.It does not show any non-conformity in regard to the reported product and failures.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2020-06-24.Based on the results the reported failure "venous bubble alarm and two arterial bubble alarms were triggered without any visible air bubbles" could be confirmed.The cardiohelp appears to have functioned to specification and no faults were found as per the service report.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.
|
It was reported that one venous bubble alarm and two arterial bubble alarms were triggered without any visible air bubbles.The event occurred during treatment.No intervention was set for the redundant venous bubble sensor.The intervention of the mandatory arterial air bubble sensor triggered the pump stop twice as per design to prevent complications of air embolism.After each pump stop the customer manually clamped the lines, aspirated from the pre oxygenator pigtail and inspected the circuit for air.No air was seen on aspiration.The treatment was continues about 1 minute and 46 seconds after the first pump stop.The patient did die many days later, according to the customer this was not at all related to this incident.The clinic did not elaborate on the cause of death.Complaint id: (b)(4).
|