During a 12 hour liver transplant, bleeding occurred from the liver bed. An attempt was made to stop the bleeding using the abc system. They encountered a "ground fault" reading which prevented activation of the abc generator. Four consecutive ground pads were applied to the pt. At one point the "ground fault" disappeared when the pad was "maneuvered", this allowed a short activation time. They could not get a pad to adhere to the pt's skin, which was described as "very oily". The bleeding could not be controlled. The pt died.

The investigation has been completed. The original complaint stating, "during a liver transplant, they applied 4 consecutive ground pads and could not get the esu (birtcher system 6000) to set- they continued to get a cord fault. The pt expired due to a loss of blood. " was received 11/15/2000. The esu ad device was not returned for eval by conmed/aspen labs, although info was related which indicated there was not likely anything wrong with the esu unit. Conmed/aspen labs filed an mdr report on this incident with the fda, based on the info provided that a death occurred. The description provided in the initial report by the hosp, indicated that the staff was having a difficult time getting the 4 pads to adhere to the pt, and kept getting pad alarms which would not allow them to use the equipment. Follow up info did indicate the unit was tested by the conmed rep in the hosp biomed shop using a new pad on his arm and contacting a banana in his hand, it apparently worked ok. The follow up description provided did state that the pt's skin was "oily" and the pads were not adhering properly. Although the follow up description provided did not state that the esu or pad sensing system (pss) was tested further by your group, with the description provided it is most likely that no operational problems would be found, particularly no pad setting problems related to the event. From the description of the events it is believed by conmed/aspen labs that the unit and pss were likely operating properly at the time of the procedure. Conmed/aspen labs regrets the incident occurred, however with the info provided, the actual cause of the pad setting alarms could not be determined. Although it is known that the esu and pss were not remaining "set" during the event, both devices were likely operating within limits. The user should be aware of the potential for pad adherence issues and that the esu's pad sensing will be likely to alarm as intended.

In 01/12/2001, conmed/aspen lab's technician went to a hosp and tested the system 6000 abc and the stand alone pad monitor. The test results were all within mfr's specifications. On 01/22/2001, risk manager was faxed a request from conmed/aspen labs for a mandatory medwatch from the hosp if the hosp determiend it was required by federal regulations. To date conmed/aspen labs have not received the hosp medwatch. This file will be closed pending receipt of a mandatory medwatch from the hosp.