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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Note: no udi number has been included in the section d4 unique device identifier (udi) since the serial number of the affected machine has not been provided.Therefore, it is not possible to identify the serial number of the machine in question and therefore its udi number.
Event or Problem Description
The event occurred in saudi arabia.It was reported that rotaflow drive was found to be defective.If the device reached 1000 rpm (revolutions per minute) the error message ¿head error¿ occurred.No more information provided.More information requested but still pending.No harm to any person has been reported.The reported failure ¿head error¿ could lead to the pump stop during treatment therefore, a report is required.Complaint id: (b)(4).
Additional Manufacturer Narrative
New information provided by the ssu (sales and service unit) date on 2025-12-22 about the time of occurrence.The reported ¿head error¿ occurred during testing and no patient was involved.No harm to any person has been reported.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.
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
New information provided by the ssu (sales and service unit) date on 2026-01-12 about the country of occurrence.It was occurred in egypt and not in saudi arabia as initially reported.Note: this event occurred on the egypt 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.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.
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: 23862084
• Report Number: 8010762-2025-0000565
• Device Sequence Number: 15777761
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/18/2026

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: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/12/2026; 05/18/2026; 06/10/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/12/2026; 05/27/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown