PORT INTRODUCER KIT
Received Jan 3, 2018 · Event occurred Dec 4, 2017
Report 7159693 · MDR key 7159693
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT CONNECTED TO ELASTOMERIC PUMP CONTAINING 5FU FOR CONTINUOUS HOME INFUSION. PATIENT REPORTED TO THE CHEMO INFUSION CENTER AROUND 11 AM TO HAVE HIS FANNY PACK REPLACED AS THE ZIPPER HAD BROKEN. AT THAT TIME, EVERYTHING WAS WORKING PROPERLY. AROUND 2PM THE PATIENT REPORTED BACK AT THE INFUSION DEPARTMENT BECAUSE THE TUBING FROM THE 5FU PUMP HAD BECOME DISCONNECTED FROM THE TUBING ON THE HUBER NEEDLE. UPON EXAMINING THE PATIENT AND THE EQUIPMENT, THE CLAVE CONNECTOR HAD BECOME LOOSENED TO THE POINT IT CAME DISCONNECTED FROM THE HUBER NEEDLING TUBING. SUBSEQUENTLY THE PATIENT HAD CHEMOTHERAPY ON HIS CLOTHING. BECAUSE THE VASCULAR ACCESS WAS COMPROMISED, THE HUBER NEEDLE WAS REMOVED.