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

Model Number VH-3010

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6), was overheating.They were able to finish the case without changing anything.No issues with vein, blood loss or burns from the "overheating".Biomed has checked the generator without finding any issues or faulty operating.They said it could possibly be the vh-4030 cord , but the cord was put back in circulation as they had not changed it during the procedure.Power setting was at "3" and no other issues during the harvest.Delay was 8-10 minutes.No patient or vein issues.

Manufacturer Narrative

Tw id# (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 Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n: (b)(6), was overheating.Device was put back into circulation.They were able to finish the case without changing anything.No issues with vein, blood loss or burns from the "overheating".Biomed has checked the generator without finding any issues or faulty operating.Power setting was at "3" and no other issues during the harvest.Delay was 8-10 minutes.No patient issues.

Manufacturer Narrative

Trackwise id#: (b)(4).The reported device is an oem device.The certificate of conformance was reviewed for the serial#: (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.H3 other text: device not returned.

• 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: 17470241
• MDR Text Key: 320782725
• Report Number: 2242352-2023-00660
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.