INFUSOR

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER POSTAL CODE: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED APPROXIMATELY 10-12 HOURS INTO THE INFUSION, RESULTING IN THE DRUG COMING INTO CONTACT WITH THE PATIENT'S SKIN. THE ISSUE WAS FURTHER DESCRIBED AS A DISCONNECTION AT THE POINT WHERE THE DEVICE ATTACHED TO THE PATIENT'S PORTA CATH POSITIVE DISPLACEMENT DEVICE. THE DEVICE CONTAINED 5825 MG OF FLUOROURACIL DILUTED IN 0.9% SODIUM CHLORIDE WITH A TOTAL VOLUME OF 230 ML. THERE WERE NO REPORTS OF PATIENT INJURY OR ANY MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.