Description of Event or Problem · 1
SWELLING AND PAIN NOTED IN LEFT UPPER EXTREMITY AND A VENOGRAM PERFORMED ON 5/1/92 SHOWED A COPLETE OCCLUSION OF THE BRACHIAL AND BASILIC VEINS OF THE ARM. COULD BE DUE TO THROMBOSIS. PHYSICIAN CONCERNED BECAUSE OF SIMILAR INCIDENT OCCURRED IN ANOTHER PATIENT, THUS THE DEVICE MAY BE CONTRIBUTING TO THE THROMBIS FORMATION. UNDETERMINED REASON FOR THROMBOSIS. REQUIRED INTRAVENOUS HEPARIN TREATMENT AND BLOOD MONITORING OF PT/PTT. PATIENT HAD A RT SUBCLAVIVAN IN FOR USE DURING THE HEALING TIME FOLLOWING THE INSERTION OF THE SEAPORT. THE SEAPORT WAS USED STARTING ON 5/3/92 AND FUNCTIONS CORRECTLYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, OTHER, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.