MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4030
Medical Device Problem Codes	Failure to Deliver Energy (1211); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital is requesting a replacement hemopro2 extension cable.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b3,b4,b5,e2, e3, g3,g6,h2,h11.
Event or Problem Description
The hospital reported that before the procedure, hemopro2 extension cable did not work.A new device was used to complete the procedure.There was no delay.There was no patient harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h11.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.The reported device is an oem device, therefore, a lot/serial history review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 23309410
• Report Number: 2242352-2025-0001129
• Device Sequence Number: 5788679
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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: VH-4030
• Device Catalogue Number: VH-4030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/11/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/12/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown