ANGIOMAT ILLUMENA

Description of Event or Problem

CUSTOMER REPORTED THAT THE TECHNOLOGIST WAS LOADING THE SYRINGE INTO THE PRESSURE SLEEVE, WHEN THE HINGE PIN AND FACEPLATE BROKEN. THERE WERE NO PATIENTS INVOLVED OR INJURIES.

Additional Manufacturer Narrative

THE INJECTOR WAS RETURNED TO THE MANUFACTURER FOR EVAL. THE FACEPLATE WAS NOT SENT WITH IT, NOR WAS THE BROKEN HINGE PIN THAT THE COMPLAINT MENTIONS. REPAIR CELL TECHNICIAN DID CONFIRM THAT THE MAIN FRAME CASTING WAS CRACKED AT THE CORNER WHERE THE HINGE PIN ATTACHES. THIS BREAK IS CONSISTENT WITH A FAILURE THAT WOULD OCCUR IF SOMEONE TRIED TO MOUNT THE FACEPLATE ON A BENT HINGE PIN AND CLOSE AND LATCH IT. THIS ALSO COULD OCCUR BY NOT SECURING THE FACEPLATE LATCH PROPERLY PRIOR TO INJECTION WHICH COULD CAUSE THE RAM TO PUSH OUTWARD, THEREBY, BENDING THE PIN AND POSSIBLY CRACKING THE FRAME CASTING. FIELD SERVICE ENGINEER REPLACED THE MAIN FRAME CASTING TO COMPLETE REPAIRS. HE CALIBRATED THE UNIT AND RAN IT THROUGH A BURN-IN TESTING. SYSTEM WAS RETURNED TO THE CUSTOMER.