80FRN HOSPIRA,INC.

THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY DURING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER LEVOPHED 4MG/250ML. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. ON (B) (6) /2010 AT AN UNSPECIFIED TIME, THE NURSE REPORTED THE DEVICE ALARMED FOR AN UNSPECIFIED ALARM CONDITION AND DISPLAYED A WHITE SCREEN. AT THAT TIME, IT WAS REPORTED THE DEVICE STOPPED DELIVERING. THE CUSTOMER CONTACT REPORTED THE PATIENT HAD A DECREASE IN MAP (MEAN ARTERIAL PRESSURE) TO BETWEEN 48MMHG TO 50MMHG. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO FURTHER MEDICAL INTERVENTIONS REQUIRED. THE CUSTOMER CONTACT REPORTED THE DELAY IN CRITICAL THERAPY WAS 5 MINUTES. FOLLOWING THE RESTART OF THE DELIVERY, THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S BLOOD PRESSURE STABILIZED TO AN ACCEPTABLE LEVEL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION.