80MEA HOSPIRA, INC.

AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICES FOR EVALUATION. IF THE DEVICES ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT IDENTIFIED BY SERIAL NUMBER, HOWEVER, THE CUSTOMER HAS IDENTIFIED FOUR POSSIBLE SERIAL NUMBERS: (B) (4). THE PUMP HISTORIES WERE DOWNLOAD AND PRINTED AT THE USER FACILITY. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE OR PROGRAMMING PARAMETERS; THEREFORE, THE HISTORIES CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. (B) (4)

THE CUSTOMER CONTACT REPORTED A DEATH WHILE THE DEVICE WAS IN USE. THE PUMP WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THE PT EXPIRED. THE CUSTOMER CONTACT REPORTED "THERE WAS NO PUMP FAILURE." DURING TESTING AT THE USER FACILITY, THE PUMP "TESTED JUST FINE." INFO WAS REQUESTED FROM THE CUSTOMER CONTACT INCLUDING THE EVENT DATE, PT'S INFO, THE NAME OF THE MEDICATION BEING DELIVERED, PUMP PROGRAMMING PARAMETERS, SPECIFIC EVENT DETAILS, ACTIONS TAKEN AS A RESULT OF THE EVENT, THE DATE OF DEATH, AND THE PT'S DIAGNOSIS. THE CUSTOMER CONTACT HAS DECLINED TO PROVIDE ADDITIONAL INFO.