BioLife Plasma cleared of wrongdoing in donor fatality involving 42 year-old male.(BIOLOGICS)

BioLife Plasma Services, Ruston, LA, Center for Biologics

A CBER-directed inspection was conducted on BioLife Plasma Services, Ruston, LA, because of a donor fatality that occurred on Dec. 9, 2005, but the blood bank was not found at fault. Investigator S. Michael Smith from the New Orleans District Office conducted the investigation.

The EIR stated that the donor, a 42 year-old male with a history of six successful donations, died approximately 90 minutes after donating plasma at the BioLife Plasma facility. "His initial physical exam was unremarkable and the donor met the donation criteria prior to each donation, giving no indication of being treated for any medical condition."

The report stated that all five previous donations were completed without interruption or problem. The donor left after each donation in good condition.

However, during the Dec. 9 donation, the subject "experienced a mild reaction at 4:18 p.m. with paleness, sweating, nausea and dizziness," the EIR noted. A total of 692 mL of plasma was collected up to that point. "The phlebotomist infused saline, provided oral fluids and applied a cold compress to the donor's head. He recovered quickly and had no additional complaints." The donation resumed and a total of 880 mL of plasma was collected.

The donor was discharged at 4:54 p.m., after the nurse talked to the donor and was satisfied he was fully recovered from the earlier incident. The subject died at 6:30 p.m.

During the investigation, Smith requested from BioLife Plasma the following records:

* Donor identification form and informed cot sent;

* Donor annual medical history and physical exam;

* Deceased's donor history card;

* Cleaning and maintenance logs;

* Post donation information report; and

* Donation history cards.

At the conclusion of the investigation, FDA stated that the investigation "failed to demonstrate any culpability of BioLife Plasma Services. Hospital and coroner records failed to shed any light on the cause of death." The agency also noted that no further investigation of the incident was planned.

BioLife was unavailable for comment. BioLife Plasma Services, Ruston, LA, 1/5/06, Doc. 109834M, $3 plus retrieval.

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