It was reported that the flow-/bubble sensor was faulty.It was later specified that the sensor was not responding.The failure was found during daily checks.No service visit was performed.The customer ordered a new flow-/bubble sensor directly from the sales department and got sent a new sensor.The log files of the reported cardiohelp device could not be provided.No exact root cause could be established.However, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: wrong bubble sensor information.Bubble sensor defective / disturbed.Environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage).Detection of no-existing bubbles.It is stated in the instruction for use (ifu) chapter 5.3.1 "connecting the combined flow/bubble sensor" 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.The review of the non-conformities has been performed on 2023-11-10 for the period of (b)(6) 2017 to (b)(6) 2023.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 2017-11-10.Based on the results the reported failure "flow-/bubble sensor not responding" could not be confirmed.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.
|