MEDEX CLEAR CUFF PRESSURE INFUSOR

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR REPORTED LOT# ABOUT THE REPORTED PROBLEM DURING LOT HISTORY REVIEW. THE SAMPLE WAS DISCARDED BY THE HOSPITAL AS NOTED IN THE COMPLAINT PRODUCT RETURN SECTION. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Description of Event or Problem

IT WAS STATED IN THE REPORT THAT WHILE MONITORING A PATIENT'S INVASIVE BLOOD PRESSURE, A NURSE DISCOVERED A LEAK IN THE PRESSURE BAG, LEADING TO BACKFLOW OF BLOOD THROUGH THE PATIENT'S ARTERIAL CATHETER. THE NURSE IMMEDIATELY REPLACED THE PRESSURE BAG AND CONTINUED INVASIVE BLOOD PRESSURE MONITORING. THERE WAS PATIENT INVOLVEMENT, WITH NO PATIENT HARM.

Additional Manufacturer Narrative

H3: DEVICE NOT RECEIVED BY MANUFACTURER.¿ A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.