Catalog Number 0684-00-0434 |
Device Problems
Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/22/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) was inserted and calibrated with no issue.After the patient procedure, on the same day of insertion, the customer noted an "unable to calibrate" alarm was generated.The customer began using the arterial lumen for blood pressure readings.There was no reported injury to the patient.
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) was inserted and calibrated with no issue.After the patient procedure, on the same day of insertion, the customer noted an "unable to calibrate" alarm was generated.The customer began using the arterial lumen for blood pressure readings.There was no reported injury to the patient.
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) was inserted and calibrated with no issue.After the patient procedure, on the same day of insertion, the customer noted an "unable to calibrate" alarm was generated.The customer began using the arterial lumen for blood pressure readings.There was no reported injury to the patient.
|
|
Search Alerts/Recalls
|