inforMED
MalfunctionMEB

DOSI FUSER ELASTOMERIC PUMP (150D2)

Received Jun 23, 2026

Report MW5189787 · MDR key 25594289

Device

Generic name

Pump, Infusion, Elastomeric

Lot number

D250838

Product problems

  • Excess Flow or Over-Infusion

Patient

NA · Unknown

  • Headache

Narrative

Description of Event or Problem

THE DOSI-FUSER ELASTOMERIC AMBULATORY INFUSION 150D2 PUMP WAS INTENDED TO DELIVER THE INFUSION OVER A 48-HOUR PERIOD; HOWEVER, APPROXIMATELY 24 HOURS AFTER INITIATION, ONLY ABOUT 3 ML OF SOLUTION REMAINED IN THE RESERVOIR. THE PATIENT SUBSEQUENTLY DEVELOPED A SEVERE HEADACHE. A SIMILAR INCIDENT OCCURRED IN A SECOND PATIENT, WITH BOTH PUMPS ASSOCIATED WITH LOT NUMBER D250838. PT: 1880. DEVICE: 1311. REF: MW5189788. THIS REPORT CAPTURES DOSI FUSER ELASTOMERIC PUMP (150D2) #1.