MalfunctionDTR

MPS 3 ND DELIVERY SET W/AA W/305CM LINE (16C)

Received Jun 8, 2026 · Event occurred Jun 3, 2026

Report 25426252 · MDR key 25426252

Device

Generic name

Heat-exchanger, Cardiopulmonary Bypass

Manufacturer

Quest Medical Inc

Catalog number

5ND3102

Lot number

78885

Patient

68 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHEN PRIMING THE MPS SYSTEM I NOTICED A LEAK FROM THE TOP OF THE ADDITIVE CARTRIDGE. I REPLACED THE ADDITIVE DELIVERY LINE, AND IT WAS STILL LEAKING. I THEN REPLACED THE ADDITIVE CARTRIDGE. UPON INSPECTION I WAS ABLE TO SEE THAT A PLASTIC NIPPLE FROM INSIDE THE LUER CONNECTION ON THE CARTRIDGE HAD BROKEN OFF INTO THE ADDITIVE LINE.