MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Model Number C-VH-3010

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Tw (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply cautery wasn't working as well.It is normally set at 2.5.Harvester feels that is a good balance of cautery and cut and control of bleeding.But today, there was bleeding every time branches were cut.Harvester reported that it is likely the generator as it is old.The cable was fine.To complete the case, harvester held pressure and when milked at the end before closing there was no bleeding.There were no procedural delays reported.Patient had a low platelet count, and surgeon gave full dose heparin while cauterizing (usually no issues with this).

Manufacturer Narrative

Trackwise#:(b)(4).Updated sections: b4, b5, g4, g7, h2, h6, h10.The reported device is an oem device.The certificate of conformance was reviewed for the serial # h10070022g.The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply cautery wasn't working as well.The power level was set at 2.5 and did not make an audible tone.Harvester feels that is a good balance of cautery and cut and control of bleeding.But today, there was bleeding every time branches were cut.Harvester noted, "it was oozy from the beginning of the case.Bleeding was controlled with spot cautery and pressure." harvester reported that it is likely the generator as it is old.The cable was fine.To complete the case, harvester held pressure and when milked at the end before closing there was no bleeding.There were no procedural delays reported.Case was completed using the same device.Patient had a low platelet count, approximately 120,000, the preop adp was abnormal, and surgeon gave full dose heparin while cauterizing (usually no issues with this).Patient was given unspecified amounts platelets and ffp.Harvester additionally noted, "we had enough conduit for the planned number of bypasses.The patient recovered well.".

• Brand Name: HEMOPRO POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18551825
• MDR Text Key: 333347767
• Report Number: 2242352-2024-00045
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-VH-3010
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CABLE
• Patient Outcome(s): Required Intervention