PRISMAFLO IIS

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS ARE NOT POSSIBLE AS THE DEFECTIVE HEATING PROFILE WAS NOT AVAILABLE FOR INVESTIGATION . SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENT REPORT WILL BE SUBMITTED. BECAUSE OF THE CHARACTERISTICS OF THIS EVENT THE MANUFACTURER JUDGES THE EVENT FITS IN THE RECALL FOR THIS PRODUCT THAT ADDRESSES THIS POTENTIAL FAILURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT WARMING SHEATH (PRODUCT CODE: UNKNOWN; SERIAL NUMBER: (B)(4)) AND THE REFERENCE NUMBER IS (B)(4). THE PRISMAFLEX MACHINE WAS SET-UP AND PRIMED FOR AN ELS TREATMENT WHEN SMOKE WAS NOTICED COMING FROM THE WARMING SHEATH. THE SHEATH WAS IMMEDIATELY UNPLUGGED, REMOVED, AND SENT TO BIOMED FOR INSPECTION. THE RENAL NURSE PRACTITIONER EXAMINED THE BLOOD LINES AND THEY DID NOT APPEAR TO BE AFFECTED, SO TREATMENT WAS STARTED WITH A NEW SHEATH. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.