A shut off of the rotaflow during patient transport was reported.On 2020-09-11 getinge received the information that the patient expired as a result of brain bleed and the customer confirmed the death of this patient was not product related.The device history record (dhr) of the rotaflow (material: 70104.3292, serial: 94175406) for which a customer complaint was received, was reviewed on 2020-09-02.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.A getinge field service technician (fst) was on site on 2020-08-28 and could not reproduce the reported failure.He replaced the battery of the rotaflow unit on 2020-11-05 in order to send the batteries to the factory for investigation.The unit was tested as per factory specifications and passed all tests.The unit was put back in use.The battery was investigated by life-cycle-engeneering on 2021-01-18 with the following outcome: 6 of 20 battery cells were found defective, which was affecting the power loss of the rotaflow.According to the service order report #43438199 the rotaflow was operated for at least one hour after the complaint event.Therefore the discovered defects must happened after the event date.Getinge is not aware of how long the rotaflow was operated with on battery during the event or if it was fully charged before.Based on these information, it is not possible to determine an exact root cause however the most probable root cause could be determined as a not fully charged battery or a battery runtime of over 1,5 hours.A medical review was performed by getinge medical experts on 2021-02-25: after the assessment of all available data no causality between the patient¿s death and the device functionality could be found.Mitigations are included in the instruction for use (ifu rotaflow| 4.2 | en | 13 ) as warnings in chapter 3.3.4 battery operation: check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.The actual run time during battery operation depends on the age and condition of the batteries, current consumption of the rotaflow console and other factors.The run time shown is only a reference value.The actual run time can be shorter or longer.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.21 was reviewed and can be linked to the reported failure as follows: the most possible causes for the reported failure "shut off of the device due to battery" are: defect batteries, software error, user forgot recharge, defect of charger unit.Based on the above mentioned investigation results the reported failure "shut off of the device" could be confirmed, but there is no relation to a product malfunction.Thus no product related malfunction lead to the patient's death and the patient expired due to causes unrelated to the nature of the complaint.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.
|