PERICARDIOCENTESIS KIT
Received Jun 18, 2025 · Event occurred May 25, 2025
Report 1721504-2025-00095 · MDR key 22288472
Device
Generic name
Fluid Drainage Tray
Manufacturer
Merit Medical RichmondCatalog number
PC101/B
Lot number
T3124395
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cardiovascular Dysfunction/Insufficiency
- Cardiovascular Dysfunction/Insufficiency
Narrative
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THE PATIENT UNDERWENT A PERICARDIOCENTESIS PROCEDURE. THE PROCEDURE WAS UNCOMPLICATED AND 500+MLS OF FLUID WAS REMOVED DURING THE PROCEDURE. THE PATIENT STATED THAT HER BREATHING WAS EASIER AND AN ECHO DEMONSTRATED A REDUCTION IN THE SIZE OF THE PERICARDIAL EFFUSION. A DRAINAGE BAG WAS LEFT CONNECTED TO THE DRAIN TO ALLOW RESIDUAL FLUID TO BE COLLECTED. THE PATIENT RETURNED TO ACCUHC VIA THE X-RAY DEPARTMENT, WHERE A POST PROCEDURE CHEST X-RAY WAS PERFORMED. THE CXR WAS REPORTED AND SHOWED A MODERATE VOLUME PNEUMOPERICARDIUM. THE AIR WAS REMOVED FROM THE PERICARDIUM VIA THE DRAIN. A FOLLOWUP ECHO DEMONSTRATED RESOLUTION OF PERICARDIAL EFFUSION BUT SHOWED THE PATIENT DEVELOPED LVSD. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.