It was reported that the arterial bubble detection was activated which caused a pump stop.According to the customer the intervention is not normally set in the clinical settings and wanted the device checked.The failure occurred during treatment.A getinge field service technician (fst) was sent for investigation and repair.It could be confirmed that the bubble intervention was active, which was not a malfunction of the device.No parts were replaced and the bubble intervention was deactivated.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and two pump stops as a result of an arterial bubble detection could be confirmed on the date of event.The root cause could be determined as the exchange of the hmi board during a previous repair, which resulted in a reset to factory settings.Therefore, the bubble intervention was active and triggered during treatment.In the instruction for use (ifu) chapter 5.3.1 "connecting the combined flow/bubble sensor" it is stated that 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.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the ifu chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.Additionally, it is stated in the cardiohelp ifu chapter 6.1 "physiological alarms and interventions" that before beginning the application, it has to be ensured that the selected warning and alarm limits, as well as interventions, are suitable and safe for the patient and the current situation and every intervention has to be checked by simulating an alarm condition.The review of the non-conformities has been performed on 2023-11-14 for the period of 2012-02-27 to 2023-11-09.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2012-02-27.Based on the results the reported failure "pump stop due to bubble detection" could be confirmed, but is not related to a malfunction of the device.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.
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