COPILOT
Received Apr 8, 2026 · Event occurred Mar 17, 2026
Report 2024168-2026-01424 · MDR key 24818664
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003331Catalog number
1003331
Lot number
60686472
Product problems
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING PREP AND DURING THE PROCEDURE, THE COPILOT DEVICE WOULD NOT STAY CONNECTED TO THE SYRINGE. WHEN THE TECH TURNED THE SYRINGE ON TO THE SIDE PORT OF THE COPILOT AND LET GO, THE SYRINGE WOULD TWIST OFF AND DROP TO THE TABLE. WHEN CONNECTING THE SIDE PORT TO PRESSURE TUBING FOR INJECTIONS A LOT OF FORCE WAS NEEDED TO MAKE SURE PRESSURE TUBING WOULD STAY CONNECTED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.