THOPAZ+ CHEST DRAINAGE SYS

Additional Manufacturer Narrative

MEDELA HAS REQUESTED THE AFFECTED DEVICE BACK FOR TECHNICAL INVESTIGATION.

Description of Event or Problem

THE NURSING STAFF NOTICED THAT AFTER CONNECTING THE SUCTION, THE PLEURAL DRAINAGE INITIALLY DID NOT PRODUCE ANY OUTPUT. ABOUT FIFTEEN MINUTES LATER, THE NURSING STAFF ENTERED THE PATIENT¿S ROOM AND FOUND THAT THE CANISTER WAS OVERFILLED AND THERE WAS A LARGE PUDDLE UNDERNEATH THE PUMP. THE PUMP DID NOT GIVE ANY NOTIFICATION SO THE PATIENT COULD NOT HAVE NOTIFIED ANYONE. AS A RESULT, THE PATIENT HAD TO BE TRANSFERRED TO THE ICU DUE TO CIRCULATORY INSTABILITY AND INTERNAL FLUID SHIFT, POSSIBLY DUE TO THE HIGH NEGATIVE PRESSURE DURING DRAINAGE.