CARTRIDGE RG MEDICATION 3ML

Description of Event or Problem

PT REPORT, THEY HAD AN SQ (SUBCUTANEOUS) SITE INFECTION A FEW DAYS AGO; PT PLACED A NEW SITE ON (B)(6) 2023 AND WAS STARTED ON A 7 DAY COURSE OF (UNSPECIFIED) ANTIBIOTICS FOR THE INFECTION. ONSET/RESOLUTION DATES/STATUS OF INFECTION IS UNKNOWN. PT REPORTS NO ISSUES WITH THEIR CURRENT SQ SITE. PT REPORTS PUMP SERIAL NUMBER (B)(6) STOPPED INFUSING ON (B)(6) 2023 AND WHEN THEY OPENED IT UP, TREPROSTINIL LEAKED OUT AND THE PUMP WOULD NO LONGER WORK. PT STATED THAT SOMETIMES THE CARTRIDGES THAT THEY GOT IN THEIR LAST 2 REFILL, HAD TROUBLE WITH THE "PLUG" WHERE THE MED WAS ADDED; IT WAS EITHER TOO TIGHT AND HARD TO REMOVE OR TOO LOOSE AND MED LEAKED OUT. PT REPORTS THEY HAD TO WASTE CARTRIDGES BECAUSE OF THIS AND THEY BELIEVE A CARTRIDGE LEAKING IS WHAT CAUSED THEIR PUMP NOT TO WORK BECAUSE MED "POURED OUT'' OF THE PUMP WHEN THEY REMOVED THE CARTRIDGE. QUANTITY AND LOT NUMBER OF EFFECTED CARTRIDGES UNKNOWN. UNKNOWN IF MD AWARE. NO ADDITIONAL INFO, DETAILS, OR DATES AVAILABLE. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE & VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS NOT APPLICABLE AS NO PUMP ALARM WAS REPORTED. PUMP RETURN TRACKING INFORMATION IS NOT APPLICABLE AS NO PUMP ISSUE WAS REPORTED. PHOTOGRAPHS WERE NOT PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. WAS INTERRUPTION IN THERAPY REPORTED? NO. IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? YES. DID WE REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES. WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY? YES. REPORTED TO CVS/CAREMARK BY: PATIENT/CAREGIVER. REFERENCE REPORTS: MW5120469, MW5120470.