MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.This event occurred on the canadian market.It is a significantly similar device to 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 70104.3292.
Event or Problem Description
The event occurred in canada.It was reported that at the flow suddenly stops on the rotaflow console.This happened twice in 3 months.The reported failure could not be reproduced.No more information provided.More information requested but still pending.No harm to any person has been reported.Due to the reported shut down a report is required.Complaint id: (b)(4).
Additional Manufacturer Narrative
The event occurred in canada.It was reported that at the flow suddenly stops on the rotaflow console.This happened twice in 3 months.The reported failure could not be reproduced.No harm to any person has been reported.Due to the pump stop during patient use a report is required.A getinge field service technician investigated the affected rotaflow console (rfc) with s/n (b)(6) and the reported failure could not be duplicated.No parts have been replaced.The device passed all performance and safety tests according to factory specifications.The device is back in clinical use.Based on these investigation results the reported failure "flow stopped" could not be confirmed.However, the failure mode can be linked to the following most possible root causes according to our risk management file: - pump stop intervention after technical error - unintended rpm change by user - unintended switch off by user - (accidental) disconnection of mains (plug).A review of non-conformities was performed on 2025-05-15 and during the time from 2016-12-07 to 2025-04-08 there are no non-conformities 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 with s/n (b)(6) was produced on 2016-12-07.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.For the affected serial number within the timeframe of the search no additional complaint was found for the same issue.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use 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.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.
Event or Problem Description
Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 21878911
• Report Number: 8010762-2025-0000179
• Device Sequence Number: 21018314
• Product Code: KFM
• UDI-Device Identifier: 04037691562445
• UDI-Public: (01)04037691562445
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 8 KG