Description of Event or Problem · 1
THE PATIENT WAS ADMITTED 2/6/92 BECAUSE OF SEVERE WEIGHT LOSS. SEVERAL ATTEMPTS WERE MADE TO PLACE A CVP LINE IN THE RIGHT SUBCLAVIAN ARTERY FOR TOTAL PARENTERAL NUTRITION. ABOUT 20 MINUTES AFTER THE PROCEDURE, IT WAS NOTED THE PATIENT HAD WEAKNESS IN HER ARM AND COULD NOT MOVE HER LEGS. ALSO, HER HEMOGLOBIN DROPPED FROM 12 TO 4 AND IT WAS FELT THERE WAS A POSSIBILITY THAT THE GUIDEWIRE HAD PENETRATED THE SUBCLAVIAN ARTERY, AND DISLODGED EMBOLIC DEBRIS INTO THE CEREBRAL CIRCULATION. THE PATIENT WAS TRANSFERRED TO ICU AND SUBSEQUENTLY EXPITRED 2/9/92DEVICE 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.