Description of Event or Problem · 1
ON 2/20/92, AT APPROX. 2300 HRS. THE PATIENT'S OXYGEN REQUIREMENTS SIGNIFICANTLY INCREASED. THE ATTENDING PHYSICIAN WAS CALLED IN TO CHECK ON THE PATIENT AND FOUND THE STOPCOCK (CONNECTED BETWEEN THE INFUSION PUMP AND THE PATIENT) IN THE OFF POSITION, THERE FORE THE PATIENT WAS NOT RECEIVING ANY PROSTAGLANDIN (PGE). THE PUMP WAS SET TO DELIVER .5 CC OF PGE. THE ALARM ON THE INFUSION PUMP SHOULD HAVE SOUNDED DUE TO THE OCCLUSION (THE STOPCOCK BEING OFF) BUT IT DID NOT. THE PATIENT WAS INTUBATED WITH 100% OXYGEN AND THE PGE WAS READMINISTERED. THE INTERRUPTION OF THE PGE MAY HAVE CONTRIBUTED TO THE INCREASE HYPOXICV CONDITION AND THE NEED FOR THE PATIENT TO BE PLACED ON MECHANICAL VENTILATION. THE AMOUNT OF TIME THE PATIENT DID NOT RECEIVE THE PGE IS NOT KNOWN FOR SURE, HOWEVER DOCUMENTATION SHOWS THE OXYGEN NEEDS BEGAN TO CHANGE SLIGHTLY APPROXIMATELY 2000 HRS. WITH SIGINFICANT CHANGES OCCURRNG AT 2300 HRS. THE PATIENT'S CONDITION IMPROVED FOLLOWING THIS INCIDENT WHEN PGE WAS RE-ADMINISTERED AND AFTER INTUBATION OCCURRED.THIS INCIDENT INVOLVES AN INFUSION PUMP THAT EITHER FAILED TO ALARM OR THE PUMP TOOK TOO LONG TO ALARM AT THE LOW SENSITIVITY SETTINGS. FOLLOWING THIS INCIDENT, THE CLINICAL ENG. DEPT. HAS CONTACTED MEDFUSION REGARDING THE CHANGING OF THE INTERNAL SETTINGS IN THE PUMPS. MEDFUSION HAS SENT THE CLINICAL ENG. DEPT. THE OCCLUSION ALARM FORCE TABLE FROM THE SERVICE MANUAL. CLINICAL ENG. MAY SET THE OCCULSION ALARMS TO A LOWER SETTING TO PREVENT FUTURE OCCURRENCES WHEN WORKING WITH VERY SMALL INCREMENTS. CLINICAL ENG. HAS BEEN AND WILL BE IN CLOSE CONTACT WITH MEDFUSION REGARDING ANY CHANGES MADE TO THE PUMPS.THE PUMP UNVOLVED IN THE INCIDENT WAS IMMEDIATELY RETURNED TO MEDFUSION FOR REPAIR TO THE SADDLE AND THE SYRINGE HOLDER IN MARCH, 1992. THE PUMP RECEIVED A QUALITY CONTROL TEST BEFORE IT WAS RETURNED TO THE HOSPITAL. HOWEVER, TH EPROBLEM WITH THE PUMP FAILING TO ALARM WAS NOT THE REASON IT WAS RETURNED FOR REPAIR IN MARCH 1992. THE PUMP IS CURRENTLY AVAILABLE FOR REINSPECTION BY MEDFUSIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.