Description of Event or Problem · 1
ON 2/25/92 THE PATIENT (A#848710) WITH DIAGNOSIS OF END STAGE RENAL DISEASE WAS NOTED TO HAVE GAINED 5.3 LBS. UPON COMPLETION OF HEMODIALYSIS. THE PATIENT BECAME SYMPTOMATIC WITH MILD DYSPNEA. THE DIALYSIS CONTROL UNIT WAS REMOVED IMMEDIATELY FOR EVALUATION. THE PATIENT WAS PLACED ON ANOTHER MACHINE FOR REMOVAL OF THE EXCESS WEIGHT. THE PAIENT DID WELL AND WAS SUBSEQUENTLY DISCHARGED. THE MANUFACTURERS, COBE GAMBRO HOSPIAL, SERVICE TECHNICIAN, WAS AVAILABLE TO INSPECT THE DIALYSIS MACHINE IMMEDIATELY FOLLOWING THE INCIDENT. THE TECHNICIAN EVALUATED THE DIALYSIS MACHINE AND FOUND A DEFECTIVE CONTROLLER UNIT ON THE DIALYSIS MACHINE WHICH CAUSED IT TO REGISTER A NEGATIVE VENOUS PRESSURE WHEN THE ACTUAL PRESSURE WAS POSITIVE . THE CONTROLLER UNIT WAS REPLACED BY MANUFACTURERDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, EXPECTED WEAR/DETERIORATION, FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER RECOMM, CONTROL SWITCHES/KNOBS/TOGGLES. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.