Description of Event or Problem · 1
ALPHA THERAPEUTIC CORP WAS FIRST NOTIFIED OF THESE EVENTS VERBALLY ON 15 MAY 1998, AND REC'D COMMUNICATION BY FACSIMILE ON 19 MAY 1998. IN ACCORDANCE WITH 606.170 B), DIST REPORTED BY TELEPHONE A DONOR DEATH THAT OCCURRED AFTER PLASMAPHERESIS. THIS IS THE FULL REPORT DUE 7 DAYS AFTER THE DEATH. FULL INFO REC'D AFTER TELEPHONE REPORT MADE WITHIN 24 HRS INDICATES THE PLASMAPHERESIS PROCEDURE WAS NOT AT FAULT AND THAT THE DONOR DIED OF UNDERLYING HEART DISEASE. DONOR WAS A BLACK FEMALE FIRST-TIME DONOR AT FACILITY. HER DATE OF BIRTH WAS 2/13/62. HER HISTORY AND PHYSICAL ON THE DAY OF DONATION SHOWED A BLOOD PRESSURE OF 150/94, PULSE OF 87, TEMPERATURE 98.3 DEGREE FAHRENHEIT, TOTAL PROTEIN OF 9.0 AND HEMATOCRIT 40. SHE GAVE A HISTORY OF PREVIOUSLY DONATING WHOLE BLOOD ON 6/97 WITH NO REACTION. SHE SAID SHE HAD STOPPED WATER PILLS ONE YR AGO AND HAD BEEN REMOVED FROM ANTI-HYPERTENSIVE THERAPY. SHE WAS 5'2" AND 166 LBS. THE PROCEDURE WAS UNEVENTFUL UNTIL THE LAST CYCLE WHEN SHE FELT LIGHTHEADED. SHE VOICED COMPLAINTS OF CHEST PAIN BUT POINTED TO HER ABDOMEN AS THE SITE OF HER PAIN. SHE ALSO EXPERIENCED SWEATING, NAUSEA, COLD, CLAMMY SKIN AND TINGLING IN THE RIGHT ARM. THE PROCEDURE WAS DISCONTINUED, LEGS WERE ELEVATED, COLD PACKS APPLIED TO HER FOREHEAD. VITAL SIGNS INDICATED BLOOD PRESSURE 90/78, AND PULSE 64/MIN. WHEN HER NAUSEA DISAPPEARED, SHE WAS OFFERED FLUIDS AND TUMS. SHE REQUESTED ASSISTANCE TO GO TO THE REST ROOM WHICH WAS PROVIDED. AFTER THIS, SHE WAS PLACED IN A BED WHERE SHE COMPLAINED OF CHEST PAIN. SHE WAS ALERT. MED ASSISTANCE WAS SUMMONED USING 911 BECAUSE OF CONCERN SHE WAS EXPERIENCING A HEART ATTACK. SHE BEGAN TO HAVE SEIZURES AND VOMITING. WHEN PARAMEDICS ARRIVED HER PULSE WAS PRESENT. HOWEVER, HER STATUS DETERIORATED AND SHE REQUIRED DEFIBRILLATION AND RESUSCITATION FOR CARDIAC ARREST. SHE WAS TAKEN BY AMBULANCE TO HOSP WHERE DIST BELIEVES SHE WAS PRONOUNCED DEAD ON OR SHORTLY AFTER ARRIVAL. SHE WAS THEN TAKEN TO THE MED EXAMINER WHERE AN AUTOPSY WAS PERFORMED. PRELIMINARY RESULTS WERE SEVERE CORONARY ARTERY DISEASE, INVOLVING ALL VESSELS WITH THICKENING AND FIBROSIS OF VESSEL WALLS. HER HEART WAS ENLARGED (450 GM). THE MED EXAMINER CONCLUDED SHE HAD SEVERE CORONARY ARTERY DISEASE. IN ADDITION, HE HAD REC'D A HISTORY OF COCAINE USE FROM THE HOSP. THEREFORE, A FINAL AUTOPSY REPORT WILL BE HELD UNTIL TOXICOLOGY IS COMPLETED, ALONG WITH MICROSCOPIC SECTIONS IN 4-6 WEEKS. REVIEW OF RECORDS OF THE PROCEDURE AND THE MACHINE USED REVEAL NO ISSUES OF CONCERN. VERBAL CONTACT WITH THE SOFT GOOD MFRS INDICATED NO PROBLEMS WITH THESE LOTS OF WHICH THEY ARE AWARE. IN VIEW OF THE CLEAR MED EXPLANATION FOR THE DEATH, NO FURTHER INVESTIGATION HAS BEEN DEEMED NECESSARY. AFTER REVIEW OF THE CLINICAL FINDINGS AT THE CTR AND THE MED EXAMINER'S REPORT, THE MED DIR OF THE FACILITY, AND DIST HAVE CONCLUDED THAT THE DONOR DIED OF ATHEROSCLEROTIC CORONARY ARTERY DISEASE.