MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, "THE PRESSURE BAG HAD DEFLATED" LEADING TO "FALSE DATA." THE CUSTOMER REPORTED THAT THE CLINICIAN BEGAN TREATING THE PATIENT FOR HYPOTENSION BY TITRATING "VASOPRESSORS BASED OFF OF THE ARTERIAL BP." PER THE CUSTOMER, "INVESTIGATION REVEALED THAT THE PRESSURE BAG HAD DEFLATED" AND THE "PRESSORS RAPIDLY TITRATED DOWN." THE CUSTOMER REPORTED "NO NEW TREATMENTS WERE NEEDED POST EVENT." THE CUSTOMER STATED "ALTHOUGH TEAM MEMBERS REPORTED THAT THE STOPCOCK WAS TURNED UPWARD TOWARD THE BAG AND THE CLAMP WAS CLOSED, I AM NOT CERTAIN THIS WAS CONSISTENTLY THE CASE." THE CUSTOMER SAID "NO ADDITIONAL OCCURRENCES HAVE BEEN REPORTED AFTER THE TEAM WAS INSTRUCTED TO ENSURE THE STOPCOCK IS TURNED TOWARD THE BAG" AND "THESE EVENTS MAY HAVE BEEN RELATED MORE TO USER ERROR THAN TO SUPPLY OR EQUIPMENT ISSUES." NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, "THE PRESSURE BAG HAD DEFLATED" LEADING TO "FALSE DATA." THE CUSTOMER REPORTED THAT THE CLINICIAN BEGAN TREATING THE PATIENT FOR HYPOTENSION BY TITRATING "VASOPRESSORS BASED OFF OF THE ARTERIAL BP." PER THE CUSTOMER, "INVESTIGATION REVEALED THAT THE PRESSURE BAG HAD DEFLATED" AND THE "PRESSORS RAPIDLY TITRATED DOWN."