MalfunctionGCD
ADDEASE 13MM BINARY CONNECTOR
Received Jun 5, 2007 · Event occurred May 29, 2007
Report MW5002543 · MDR key 863995
Device
Product problems
- Premature system activation
- System fails to activate
Patient
Not reported
- Missed Dose
Narrative
Description of Event or Problem
ADDEASE 13MM ACTIVATED PRIOR TO SHIPPING. PRODUCT WAS STORED AT ROOM TEMPERATURE. PRODUCT ALSO ACTIVATED IN PATIENT'S HOME WITHIN 24HRS OF DELIVERY. DRUG DOSES HAD TO BE WASTED. PATIENT ALSO HAD PROBLEMS WITH ACTIVATION. WHEN DILUENT WAS SQUEEZED IT WOULD NOT RELEASE FLUID INTO VIAL FOR 6 DOSES. PATIENT MISSED DOSES OF ANTIMICROBIAL THERAPY WITH CURRENT DIAGNOSIS OF MRSA. THERAPY HAD TO BE CHANGED DUE TO MULTIPLE ISSUES WITH ADDEASE.