PHASEAL
Received Apr 26, 2017 · Event occurred Apr 25, 2017
Report MW5069393 · MDR key 6529551
Device
Generic name
Phaseal
Manufacturer
BdProduct problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
OUR HOSPITAL JUST STARTING USING PHASEAL CLOSED SYSTEM FOR OUR CHEMOTHERAPY PT. THE RATIONALE FOR THE DEVICE IS THAT IT IS A CLOSED SYSTEM AND PREVENTS EXPOSURE OF HAZARDOUS DRUGS A HEALTH CARE WORKER COMES IN CONTACT. THIS IS A REQUIREMENT FOR USB 800 COMPLIANCE. WE SENT A PT HOME WITH A 24 HOUR CHEMO PUMP THAT WAS HOOKED UP WITH ALL THE NECESSARY PHASEAL CONNECTIONS AND THE CONNECTIONS WHERE TAPED AS WELL. IT APPEARS AS THE Y CONNECTOR ON THE DRUG BAG WAS LEAKING CHEMO. THE PHASEAL REP WAS ONSITE TO SEE AND INSPECT THE INTEGRITY OF THE SYSTEM. THE ONLY REASON SHE COULD COME UP WITH WAS THE CONNECTOR WAS ACCESSED >10 TIMES FOR IT TO BE COMPROMISED. SHE IS DOING A FURTHER INVESTIGATION WITH THE PHARMACY AND HER COMPANY.