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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2023

Event Type  malfunction  

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 had poor sealing and electrical interference (lines/static) on screen.They requested that power generator be taken out of rotation.They were able to finish the case with the generator that was causing issues since it was only a thigh on the left leg.They measured the biggest branch after the vein was out and it was 4-5mm.

Manufacturer Narrative

Trackwise id #(b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A serial number was not provided and the specific product serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply had poor sealing and electrical interference (lines/static) on screen.They requested that power generator be taken out of rotation.They were able to finish the case with the generator that was causing issues since it was only a thigh on the left leg.Harvest was delayed but completed.They measured the biggest branch after the vein was out and it was 4-5mm.The power setting was between 2 and 2.5.Advised customer that for proper function of vasoview hemopro 2 harvesting device, the ifu recommended power setting is 3.They stated that the device was not sealing fast enough.There were no reported effects to patient.

• 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: 17510385
• MDR Text Key: 321290763
• Report Number: 2242352-2023-00665
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• 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: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 92 KG