CARTRIDGE RG MEDICATION 3ML

Description of Event or Problem

SPONTANEOUS: PT REPORTED REPEATED PROBLEM WITH HER CARTRIDGES/MS3 PUMP. FEW TIMES WHEN SHE WAS ABOUT TO CHANGE CARTRIDGE THERE WAS A LEAK INSIDE THE PUMP. SHE SPOKE WITH CNSS AND POSSIBLE CAUSE IS FAULTY CARTRIDGES AND CNSS SUGGESTED TO EXCHANGE PUMP THAT WAS EXPOSED TO LIQUID FEW TIMES. NO SIDE EFFECTS REPORTED , IT WAS ONLY CARTRIDGE LEAKING INTO THE PUMP. SERIAL NUMBER OF THE PUMP THAT WILL BE EXCHANGED (B)(6). NO ADDITIONAL INFORMATION, DETAILS, OR DATES AVAILABLE. PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE & VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; DID WE [MFR] REPLACE THE DEVICE? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER. REFERENCE REPORT #MW5145150.