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It was reported that the displayed flow of the rotaflow is inaccurate.The customer used an external flow meter.The external flow meter displayed a flow of 600 ml less flow that the rotaflow is displaying.The failure occurred during patient treatment.The patient suffered from an ischemic bowel.The patient expired.During the inspection of the device by a getinge in-house technician it was found that the closing assy is broken, part of the ucu kit needs to be replacement and control panel foil next to the level sensor button is torn.The supplier emtec confirmed the broken closing assy and found the following addition failures in the roaflow drive.The o-ring between the block and cap is damaged and the flow sensor has a corner that is broken off.The affected drive (serial#(b)(6) and the affected console (serial#(b)(6) were sent back to the manufacturer for repair.It was received on 2022-06-28 and during investigation by the getinge service department on 2022-06-30 the reported failure "flow inaccurate" could not be confirmed.Thus, the drive was sent to the supplier emtec for further investigation and repair.On (b)(6) 2022 the supplier emtec was unable to reproduce the reported failure "flow inaccurate".The drive has a maximum flow deviation of 1,759%.This deviation is within the required flow accuracy of 7%.On 2022-09-12 the rfd closing assy (material#70101.1680) with rubber pin and flow sensor have been replaced.The most probable root cause for the "broken closing assy" and "broken off corner on the flow sensor" could be determined as mishandling.On 2022-09-20 a getinge service technician repaired the affected rotaflow console (serial# (b)(6).The technician replaced the rf (rotaflow) icu cover for switch (material#70107.3409) front panel assy rotaflow (material#70104.5649) and the hl20_rubber foot 24x12 rpm/tpm (material#70105.4567).According to the rotaflow risk management file the most probable root cause for the "broken icu cover" "replacement rubber foot" and "torn control panel foil" could be determined as.Malfunction or total fail due to mechanical influences, e.G.: 1.Falling of rotaflow system (broken holder, user routine violence).2.Collision with environment during patient transport.3.Loosening of fastening (wrong installation, aging).Based on these investigation results the reported failure "broken closing assy" and "broken off corner on the flow sensor" as well as "broken icu cover" "replacement rubber foot" and "torn control panel foil" could be confirmed.Based on these investigation results the reported failure "flow innacrate" could not be confirmed.However, the failure mode "flow inaccurate" can be linked to the following most possible root causes according to the rotaflow risk management file.Malfunction of the flow measurement system: 1.Zero flow calibration failed.2.Incorrect flow measurement.3.Device used out of specification.Bubble/flow sensor failure, e.G.: 1.Malfunction of bubble/flow sensor electronics.2.Dried contact gel.3.User forgot renewing contact gel.4.Mechanical defects (impact).5.Sensor not detected although sensor is connected.6.Device used out of specification.After functional test at getinge service department on 2022-09-20 the device was sent back to the user.The reported failure and the application method described by the customer was evaluated by getinge medical affairs department on 2022-09-26 with the following outcome: based on the outcome of the investigation report and the service report, the rotaflow and the rotaflow drive flow measurement appears to be within expected and declared deviations.However, it could be that the broken closing bracket of the rotaflow drive, or a calibration issue of one of the sensors, or both, contributed to the deviations regarding the measured flows.In general, mild deviations from device to device (and/or from manufacturer to manufacturer) are to be expected.The customer mentioned that it is difficult to say if there was any patient harm directly from this event because the patient was severely ill and expired about 24 hours after the offset was reported.Because the device was not changed within the 24 hours of support, it is assumed that the product provided the requisite support to the patient despite the expiration due to complicating comorbidities.Therefore, it is challenging to attribute a diminution in performance to the getinge product (rotaflow).Rotaflow console: the review of the non-conformities has been performed on 2022-08-09 for the period of 2015-09-15 to 2022-05-03.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.The product in question was produced in 2015-09-15.Rotaflow drive: the review of the non-conformities has been performed on 2022-08-09 for the period of 2015-09-15 to 2022-05-03.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.The product in question was produced in 2015-09-15.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.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.
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