MalfunctionBSB
BUDDY LITE
Received Dec 8, 2025 · Event occurred Nov 29, 2025
Report MW5180127 · MDR key 23749422
Device
Generic name
Warmer, Blood, Non-electromagnetic Radiation
Manufacturer
Belmont Medical TechnologiesProduct problems
- Material Rupture
Patient
53 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SPONTANEOUS RUPTURE OF BUDDY LITE CARTRIDGE. SN: (B)(6) WHILE INFUSING PACKED RBCS TO PATIENT, THE CARTRIDGE RUPTURED RESULTING IN APPROXIMATELY 20 ML OF LOST PRBC. INFUSION WAS GRAVITY DEPENDENT WITH NO PRESSURE APPLIED. PATIENT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THE EQUIPMENT FAILURE. CARTRIDGE WAS REMOVED AND INFUSION WAS CONTINUED.