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

Model Number	ROTAFLOW DRIVE UNIT, BLUE
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Death
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.Note: this event occurred on the german market.It is a significantly similar device to "base unit, rotaflow drive¿ 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 drive with catalog number 701022161.
Event or Problem Description
The event occurred in germany.It was reported that during preparation for a planned ct scan ¿ planned in-house patient transport with va ecmo from the intensive care unit to the ct ¿ the rotaflow drive unit was positioned in the patient bed as per instructions.The drive pump was running correctly at a flow rate of 2.6 l/min.Suddenly, the rotaflow flow indicator alerted, and the flow indicator was no longer readable.At the same time, a significantly louder rotation noise from the drive pump was audible.An immediate, complete inspection revealed that air had entered the system.The arterial line was immediately clamped, and the ecmo speed was completely reduced.After immediately clamping the arterial line and reducing the ecmo speed, the perfusionists were immediately informed, with the urgent instruction to immediately transfer a filled, ready-to-use system to the intensive care unit.The subsequent inspection of the ecmo system together with the attending physicians revealed no visible damage to the ecmo.Analysis: during the ukr's analysis of the affected products, no undesirable side effects, no malfunction, no application error, and no inadequacy of the information provided were identified.Although we have exhausted our analytical capabilities, we cannot completely rule out the above-mentioned error possibilities, and therefore we are reporting the fatal patient injury resulting in death.Due to the police investigation, the disposable products are no longer within our control.The lot information for the involved disposable products are therefore not available.The other hardware is securely stored at the ukr.Due to the reported death a report is required.Complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided by the getinge ssu (sales and service unit) as follows: due to the patient's pre-existing medical conditions and the poor prognosis that already existed before the incident, a customer decision was made against changing the set and treatment was discontinued.The investigation is ongoing.No further information is available right now for product investigation.The products are still confiscated.On (b)(6) 2025 the telephone number and the file reference number (b)(4) of the regensburg public prosecutor was provided by the ssu (sales and service unit), further communication will be performed by maquet cardiopulmonary gmbh.A follow up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided by the getinge ssu (sales and service unit) as follows: a phone call between getinge dcu (designated complaint unit) team lead, senior complaint handler, and the public prosecutor¿s office from (b)(6) took place on (b)(6) 2026 at 14:30 pm.During this call, the person at the hotline there confirmed the case number (b)(4) provided to the manufacturer is incorrect.The ssu was contacted on the same day on (b)(6) 2026 to request the correct case number at the hospital as soon as possible.New information was provided by the ssu on 2026-03-17 that a conversation was held with mr.(b)(6) from the legal department at the (b)(6) hospital and hospital is not willing to share the correct file number due to ongoing investigations.They further informed that getinge will be informed as soon as the involved devices (rotaflow/pls/cannulas) has been released.A follow up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided by the getinge ssu (sales and service unit) as follows: on 2026-04-08 the ssu has been provided new case number by (b)(4) of the regensburg public prosecutor and telephone number (b)(6).A follow up medwatch will be submitted when additional information becomes available.
Event or Problem Description
Complaint id: (b)(4).
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
A phone call between getinge dcu (designated complaint unit) team lead, and the (b)(6) criminal investigation department (b)(6) took place on (b)(6) 2026 at 14:35 pm.During this call (b)(6) reported that an external investigation was ordered (b)(6) 2026 by an independent expert.This investigation is ongoing.(b)(6) will inform getinge as soon as the final report was received.A follow up medwatch will be submitted when additional information becomes available.

• 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: 22794352
• Report Number: 3013876692-2025-00066
• Device Sequence Number: 8315064
• Product Code: KFM
• UDI-Device Identifier: 04037691258997
• UDI-Public: (01)04037691258997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/12/2026
• Report Date (Section F): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2026
• Device Age: 11 YR
• Date Report to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/24/2025; 03/17/2026; 04/08/2026; 05/05/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/08/2026; 03/24/2026; 04/29/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Date Report Sent to FDA: 05/12/2026