Model Number VASOVIEW HEMOPRO 2 |
Device Problems
Inflation Problem (1310); Output Problem (3005)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Trackwise 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, vasoview hemopro 2 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Event Description
|
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
Trackwise # (b)(4).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
|
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
|
|
Manufacturer Narrative
|
Corrected section: h6 device code description changed.Trackwise # (b)(4).The lot # 25153749 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory for evaluation on 03/04/2021.An investigation was conducted on 03/16/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt body.There were no visual defects observed on the btt.A mechanical evaluation was conducted.5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.A leak was observed on the side of the silicone balloon.The btt was unable to be inflated.No visual defects were observed on the silicone btt.Based on the condition of the device, the reported failure "inflation issue" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.
|
|
Search Alerts/Recalls
|