INFUSOR

Additional Manufacturer Narrative

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 WAS LEAKING FROM AN UNSPECIFIED LOCATION BUT WAS SUSPECTED THAT ¿THE BLUE BAP WAS NOT ON PROPERLY¿. THE DEVICE LEAK WAS CONTAINED WITHIN THE SEALED OVERPOUCH. THIS ISSUE WAS OBSERVED IN THE HOSPITAL PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.