Heart Lung Machine

Description of Event or Problem

The event occurred in China. It was reported that the RotaFlow Console stopped unexpectedly without any alarm during patient use. The device was placed on a blanket, which blocked the cooling fan. The device was switched off to allow cooling and was subsequently restarted. After restart, the console operated normally and no malfunction could be identified. During the period in which the console was not operating, the customer used the hand crank to maintain circulatory support for the patient. No harm to any person has been reported. Due to the reported pump stop during patient use and the hand crank was used a report is required. Complaint ID: (b)(4)

Additional Manufacturer Narrative

The event occurred in China. It was reported that the RotaFlow Console stopped unexpectedly without any alarm during patient use. The device was placed on a blanket, which blocked the cooling fan. The device was switched off to allow cooling and was subsequently restarted. After restart, the console operated normally and no malfunction could be identified. During the period in which the console was not operating, the customer used the hand crank to maintain circulatory support for the patient. No harm to any person has been reported. Due to the reported pump stop during patient use and the hand crank was used a report is required. The affected RotaFlow Console (S/N (b)(6)) was investigated by a Getinge Field Service Technician. During the investigation, no device malfunction could be identified or reproduced. According to the customer, the console had been placed on a blanket, which obstructed the cooling fan and restricted airflow. As a result, the device overheated. After allowing the unit to cool down, it resumed normal operation without any further issues or malfunctions. Based on the investigation results, the reported event could be confirmed; however, no product-related malfunction was identified. The observed behavior was attributed to the operating conditions that led to inadequate ventilation and subsequent overheating. The review of the non-conformities was performed on 2026-07-24 and during the period of (B)(6) 2022 to (B)(6) 2026 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 RotaFlow Console in question was produced in 2022-07-12. In addition, a review for potential Field Actions and CAPAs related to the failure and product in this complaint was performed. This complaint is not in scope of any ongoing Field Actions and/or CAPAs. The following IFU section should be followed in case of a "pump stop" HEART-LUNG SUPPORT SYSTEM ROTAFLOW System/ 4.4 / EN / 15. Chapter 2.2.4 General Precautionary Measures During Use If the pump stops during an application, the blood flow will be interrupted and supply to the patient will cease. Eliminate the cause of the pump stop and start the pump again as soon as possible. 2.2 General Safety Instructions There is the risk that acoustic alarms emitted by the ROTAFLOW System may not be heard. You should therefore position the system so that you can see the displays on the ROTAFLOW Console and any optical warning signals at all times. Furthermore, the following section should be followed in case of a "device overheat" Chapter 2.2.1 General Risks in the Use of Heart-Lung Support Systems Make sure that the ventilation openings are not obstructed and the ROTAFLOW System is not covered. There is a risk that the ROTAFLOW System will overheat. Ensure a minimum distance of 50 cm to other devices, objects, or the wall. 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. Note: This event occurred on the Chinese market. It is a significantly similar device to "base Unit, Rotaflow Console¿ which is sold in the USA under premarket submission number K991864. For section D4 all available identifying information is for the out of the US device, subjected to this report. Therefore, no GUDID information exists. Furthermore, UDI information (primary DI number) provided in D4 is for Rotaflow Console with catalog number 701046405.