I.V. SOLUTION ADMINISTRATION SETS WITH STOPCOCKS

Description of Event or Problem

IT WAS REPORTED THAT A THEATRE ADMINISTRATION SET FOR BLOOD AND BLOOD COMPONENTS LEAKED FROM THE DRIP CHAMBER WHILE IT WAS BEING PRIMED WITH SALINE SOLUTION. THE ISSUE OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE ACTUAL DEVICE AND A VIDEO WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE VIDEO CONFIRMED A LEAK FROM THE DRIP CHAMBER. HOWEVER, A VISUAL INSPECTION OF RETURNED SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL LEAK TEST WAS PERFORMED ON THE RETURNED SAMPLE, AND A LEAK AT LEVEL OF THE HEAT SEAL CHAMBER WAS IDENTIFIED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, IT COULD BE RELATED TO MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.