TRAM®P
Received Aug 27, 2025 · Event occurred Jun 15, 2025
Report 1721504-2025-00312 · MDR key 22910002
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Merit Medical Systems Inc.Catalog number
502011005
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
- Sepsis
- Embolism/Embolus
- Unspecified Tissue Injury
- Unspecified Infection
- Sepsis
- Embolism/Embolus
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT TTHE DEVICE WAS USED FOR BLOOD PRESSURE MEASUREMENT AND TO MANAGE DIRECT FLOW AND DELIVERY BETWEEN THE MANIFOLD PORTS. DURING USE OF THE DEVICE THE PATIENT EXPERIENCED AIR EMBOLI, CLOTTED CATHETER AND BLEED BACK. SEPSIS/INFECTION AND SOFT TISSUE INJURY. NO ADDITIONAL TREATMENT WAS REQUIRED NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.