MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problem Improper Flow or Infusion (2954)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, trocar in the vasoview hempro 2 was not delivering co2 and they had to switch the co2 tubing to the distal co2 port on the harvesting cannula.Along with a getinge's rep, on site, they did a visual inspection of the trocar and it appeared to be in good condition.Once harvest was completed, they handed the trocar from the sterile field and they connected it to a spare insufflation device to try to replicate the problem.Trocar co2 delivery worked.They replicated the problem by uncoupling co2 tubing and putting it on where the blue valve was not depressed and co2 did not flow thru trocar.Getinge's rep did an in-service for the techs showing them that the blue valve inside the coupler for co2 port needs to be completely depressed for co2 to flow thru the trocar.If problem happens again, he instructed them to check the co2 tubing connection to co2 port on trocar.No patient effects,.

Manufacturer Narrative

Trackwise id(b)(6) the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 10/10/22.An investigation was conducted on 10/17/22.Only the btt was returned for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the btt.No visual defects were observed on the btt.A mechanical evaluation was conducted.The btt was able to be inflated.No visual or physical defects were observed on the silicone of the btt.A 5cc syringe filled with saline was attached to the co2 line on the btt.The syringe was depressed to spray the saline.There was no backflow observed in the co2 line.Based on the returned condition of the device and investigation results, the reported failure "improper flow or infusion" was not confirmed.A lot history record review was completed for lots 25162470, 25162587, 25162776, the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 15591038
• MDR Text Key: 305544439
• Report Number: 2242352-2022-00841
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR