Description of Event or Problem · 1
NEW COROMETRICS MONITOR WAS PUT INTO SERVICE IN NICU ON 2/13/92. PATIENT WAS A 25 WEEK GESTATION MALE THAT WAS HAVING BP MONITORED VIA UMBILICAL ARTERY CATHETER CONNECTED TO THE COROMETRICS MONITOR. WHEN THE MONITOR WAS SET UP IT WAS SET TO MEASURE BP BY CM OF H20 INSTEAD OF THE STANDARD MHG. THEREFORE, READING OF MEAN BP WERE HIGHER BY APPROX. 20MM. PHYSICIAN TREATED PATIENT WITH HYDROLAZINE, 0.2MG IV Q 3 HOURS PRN FOR MEAN BP GREATER THAN 90. ON 2/17/92 PATIENT DEVELOPED PULMONARY HEMORRAGE AND THE ERROR OF MONITOR SETUP WAS DISCOVERED. AT THIS POINT IT IS DIFFICULT TO DETERMINE IF ERROR WITH MONITOR SETUP CONTRIBUTED TO PATIENT'S PULMONARY HEMORRAGE AND SUBSEQUENT INTERCEREBRAL HEMORRAGE. PATIENT WAS AT RISK FOR THESE COMPLICXATIONS BECAUSE OF UNDERLYING MEDICAL CONDITION, PREMATURITY 25 WEEKS OF GESTATION. ON 2/17/92 MONITOR WAS CHANGED AND THE PATIENT'S BP WAS WITHIN NORMAL RANGE, NOT REQUIRING HYDROLAZINEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: INVALID DATA, DEVICE FAILED DURING ASSEMBLY. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.