DOSI FUSER ELASTOMERIC PUMP (150D2)

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: MW5189787. THIS REPORT CAPTURES DOSI FUSER ELASTOMERIC PUMP (150D2) #2.