It was reported that the hls pump made unusual noises during priming and the pressure were not able to be zeroed.The device was not being used for treatment.The used cardiohelp is handled under complaint# (b)(4) (mfg report number 8010762-2021-00240).The user tried to prime a second hls set for the same patient and could not achieve any flow.That issue is handled under complaint# (b)(4) (hls, mfg report number 8010762-2021-00223) and (b)(4) (cardiohelp, mfg report number 8010762-2021-00241).The customer provided a video of the hls set in use.The reported noise was heard.Device history record: the production records of the affected hls module were reviewed on (b)(6) 2021.According to the final test results, the oxygenators with sn (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Product investigation: for further investigation the hls set was send to ecri.The hls module was connected to a cardiohelp (complained under (b)(4)) and primed without any issue.No noise was noted during different flow and rpm settings.No malfunction could be confirmed.The involved cardiohelp (complaint# (b)(4)) was checked by a getinge service technician on (b)(6) 2021 and no noise or sound could be reproduced (refer service report (b)(4)).In addition the log files were reviewed by getinge engineering (life cycle engineering) and no error or issue could be determined.For further investigation the hls set was investigated by the getinge laboratory on (b)(6) 2021.Upon visual inspection no abnormalities were noticed.The hls set was primed and the functionality of the pump and sensors was tested.All pressure sensors could be zeroed and no unusual pump noise was found.The product worked according to its specifications, no issues were noticed.Medical evaluation: a medical review was performed by getinge medical affairs.Examinations of the cardiohelp system (sn (b)(6), a ch) by getinge and the ecri investigation of the second cardiohelp system (sn (b)(6), b ch) were not able to duplicate the issues reported by the customer in this complaint.Additionally, no performance issues with two differing disposables (a hls and b hls) could be identified in ecri tests.Moreover, no warnings, deficiencies, or low, medium, high, critical priority errors were shown in an examination of the user and service pool information by life cycle engineering.The complaints mentioned that the patient expired while waiting to be placed on support using the cardiohelp system; however, no evidentiary, direct (root) cause of the patient¿s expiration can be assigned to a malfunction of the cardiohelp system or to its associated disposables (hls set).In the absence of more details, it remains unclear if the events reported by the user (i.E.Noise, inability to zero the pressure sensors, and lack of flow) were due to either a single use error or combination of use errors.However, the possibility cannot be completely dismissed.Conclusion: while the review included an evaluation of technical, medical, trending and device history records (manufacturing); it could not be confirmed that the reported failures may be associated with a medical device malfunction.Additionally, the investigation results supported that the reported failures ¿pressure calibration issue¿ and ¿unusual noise¿ could not be confirmed.The occurrence rate was calculated for the reported failure 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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