[141241830]
Donor death during plasma donation. When did this death happen? Date: (b)(6) 2019. Time: time of adverse event was 09:57am. During donation? If so cycle? : yes, donor was at 349 ml, 5 cycles. During the donation were there any signs/symptoms of the donor or did any alarms occur? : donation went normal until the donor starting having a seizure, alarm 3508 poor flow went off once the donor started seizing. Did the donor go to the er and seek medical attention? : donor left via ambulance and was taken to the er. What device serial# did the donor donate on? : serial # (b)(4). What disposables were used with this donor? : set - lot# -fa19a30038, needle - lot# -181025c1, saline - lot#-y293803, a/c - lot#- y291344, bottle - lot# - fa19a07390. Per email from customer on 3/11/2019, they do not have a medical director's report. Customer has the initial report sent to the fda. See below for report: facility address (where donor donated): (b)(6). Fda registration number: (b)(4). Date of donation (b)(6) 2019. Date of fatality (b)(6) 2019. Type of donation (i. E. , whole blood, source plasma, apheresis platelets, etc. ): source plasma. Age/gender of donor: (b)(6), date of birth (b)(6), gender = male. Name: (b)(6). Brief history of events including any reactions noted during donor visit and measure taken to assist the donor. If the reaction occurred after leaving the premises, please include how the information was obtained/discovered, any events that took place, and where the donor was taken (hospital information), if known. Donor arrived to donate; donor began automated enrollment in health history at 9:11 a. M. Vitals: weight (b)(6), bp-systolic 123, bp-diastolic 58, pulse 72, hematocrit 49. 0, total protein 6. 6, temperature 96. 6 f. There were no re-takes of any vitals. Donor went to the donor floor at approximately 9:30 a. M. Donor was interacting normally with staff (donor floor video is available for the entire incident). Donor is a regular donor, commonly donating since 2007. Venipuncture was successfully performed at 9:36 a. M. Procedure continued as normal; donor was seen interacting with other donors, staff and was actively using his phone (texting, using the internet, etc. ). At 9:57 a. M. , the donor next to mr. (b)(6) alerted staff that something was happening. Donor was found to be visibly shaking, as in a seizure. The medical staff was immediately called to attend the donor; the plasmapheresis procedure was terminated. Medical staff found the donor unconscious but breathing. Plasmapheresis procedure was terminated at 349 mls (donor typically donates 880 mls). Medical staff applied a cold compress to his head and neck and attempted to take vital signs. Medical staff was unable to obtain vitals and 911 was called at 10:00 a. M. Medical staff continued to administer smelling salts but were unable to awaken the donor. Stethoscope was placed on the donor's chest, and it was determined that the donor had stopped breathing. Donor was moved to the floor (a flat surface); ems arrived at 10:07 a. M. Ems applied cpr; the donor was shocked several times, and a rhythm was established; ems was unable to take/establish vitals. Ems continued to work on the donor for approximately 15 minutes. At 10:26 a. M. , donor was taken by ems to (b)(6) hospital, (b)(6). (b)(6) police department arrived at the donation center at 1:00 p. M. To obtain information regarding the donor, and informed the center manager that mr. (b)(6) had passed away. All soft goods have been secured and the autopheresis device removed from service pending further investigation.
Patient Sequence No: 1, Text Type: D, B5