In 2001 baxter bioscience division medical director received info from a donor center medical director advising her of a donor who became ill during a plasmapheresis procedure, was transported to a local hospital and expired shortly thereafter.

Follow up investigation by fenwal ps identified: in 2001 baxter bioscience div's medical dir rec'd info from a donor center medical dir advising her of a donor who became ill during a plasmapheresis procedure, was transported to a local hosp, and expired shortly thereafter. The donor complained of nausea and vomited shortly after starting the plasmapheresis procedure. Approx 120ml of "wb" had been processed when the donor complained of not feeling well. Donor's donation was discontinued. Donor stated felt better immediately after vomiting. The donor told the operator donor had burritos for lunch and that donor felt this was the source of donor's ill feeling. The donor was provided with two small cups of water and allowed to rest. Donor's blood pressure, pulse and respiration were monitored and donor's blood pressure and pulse returned to near donor's baseline (what it was at the time of pre-donation screening) and donor was no longer diaphoretic or anxious within approx 10 mins. The donor was in the process of leaving the facility and then walked into the physician's substitute's office and complained of "hot flashes" and was diaphoretic. Donor was assisted to the examination table. Donor complained of "mid-line epigastric area chest pain" which progressed to "severe mid-line back pain" according to the nurses attending to donor. An ambulance was immediately summoned. The donor remained lucid and responsive throughout. The ambulance arrived in approx 7 mins and departed to transport the donor to the hosp. At the donor's request donor's "friend" was contacted to advise that donor was being transported to the hosp. The center's medical dir, was notified by telephone. The donor center later rec'd a telephone call from the donor's friend indicating that donor had suffered a seizure of some type, after arriving at the hosp, and the donor did not survive. A copy of the autopsy report will be provided once it becomes available. With communication with the medical examiner's office it typically takes 30 days to receive the final report. The center's medical examiner spoke with a rep of the medical examiner's office on 12/1/2001 and was advised that the preliminary autopsy results indicated that the deceased had "massive coronary heart disease" and that donor's heart looked like that of a 70 year old person. The co will provide add'l info as it becomes available. Sample eval: sample was obtained with no mfg defects noted, eval of plasmapheresis kit showed no anomalies. A review of the batch records did not reveal any mfg process which might have contributed to this event. A review of the fenwal complaint database did not identify any similar reports for this lot of product.

Continuation from section b6 relevant tests/lab data: autopsy performed on 12/1/01 with results received by baxter bioscience medical dir on 4/5/02. Baxter product surveillance received autopsy report on 4/11/02. Autopsy report revealed two diagnoses: 1) arteriosclerotic cardiovascular disease: severe atherosclerosis with thrombotic occlusion of the proximal left anterior descending coroanry artery and severe atherosclerosis of hte distal right coronary artery. Extensive infarct involving primarily the anterior wall of the left ventricle with focal involvement of the post-lateral and posterior walls, the interventricular septum and right ventricle. Mild aortic atherosclerosis noted as well. 2) pulmonary congestions and edema. Cause of death was reported from medical examiner as arteriosclerotic cardiovascular disease. Manner of death listed as natural.