Description of Event or Problem · 1
ON 17 JUNE 93, A 65 Y/O WOMAN WITH CHRONIE RENAL FAILURE WAS TAKEN TO THE OR FOR PLACEMENT OF A-V FESTULA AND ACCESS CATHETER. GENERAL ANESTHERIA WAS USED. THE A-V FESTULA WAS CONSTRUCTED IN THE RIGHT UPPER ARM AND THEN ATTENTION TURNED TO PLACEMENT OF THE PERM CATH USING AND AKCESS CATHETER.INITIAL ATTEMPT AT PLACEMENT WAS TUBED USING A RIGHT SUBELOVIAN VEIN APPROACH; BUT, DUE TO KINKING OF THE SHEATH, THE CATHETER WOULD NOT PASS AND A GUIDE WIRE WOULD NOT PASS BOCK INTO THE SUBCLONIAN VEIN. AN ADDITIONAL 2 ATTEMPTS AT RIGHT SUBCLONIAN VENIPUNCTURE WERE DONE WITHOUT SUCCESS. THEREFORE THE LEFT SUBCLONION VEIN WAS LOCATED ON THE FIRST ATTEMPT AND A GUIDEWIRE PASSED USING FLOUROSEAPIC CONFERMATION OF GUIDEWIRE PLACEMENT. THE INTRODUCER WAS THEN PASSED OVER THE GUIDEWIRE AND REMOVED LEARNING THE SHEATH IN PLACE. AS THE AKCESS CATHETER WAS BEING PASSED IN TO THE SHEATH, THE PATIENT BECAME HYPOTENSIVE AND SHORTLY THERE AFTER BECAME BRADYCADIC, ATRO PINE WAS GIVEN AND ASPIRATION OF BOTH PLEUAL SPOUS DONE AS IT WAS ASSUMED THAT THE PATIENT HAD DEVELOPED A PNEUMO-THOROX. NO FILL AIR WAS PRESENT, HOWEVER, AT THIS TIME EXTERNAL CARDIAC MASSAGE WAS INITIATED AND A CHEST TUBE INSERTED INTO THE RIGHT CHEST. APPOXIMATELY A LITER OF DOCK BLOOD WAS REMOVED IN A MATTER OF 20-30 SECONDS. FURTHER RESUSCETATION USING BLOOD AND COLLID WAS INITIATED AS WELL AS A VASO PRESSOR.THE RIGHT CHEST WAS OPENED AND ENTERNAL CARDIAC MASSAGE BEGUM. THE MEDIASTINAL PLEURA WAS DISCOLORED AND HULGING FROM AN UNDERLYING HEMATOMA. THE PATIENT COULD NOT BE RESUSRESUCCESSFUL AND EXPIRED IN OR.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.