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Customer (american red cross arc) reported :amicus platelet collected on 06/20/2020 (exp.06/25/2020), amicus lot fa20d28132.Collected in facility 018, manufactured in facility 016.Two platelet products from this donation, pcode e7002v00 was distributed to a hospital in (b)(6) and was transfused without incident.Product e7003v00 was shipped to a hospital in (b)(6) following a site to site shipment from (b)(6).Bact testing was negative after 5 days, hospital verbally reported a septic transfusion reaction to dcsc on (b)(6) 2020.On 06/30/2020, dcsc was notified patient post transfusion culture and residual product cultures are positive for acinetobacter haemolyticus.This not a fatality.Arc internal number is (b)(4).From arc: the platelet was collected by (b)(6) region.Two platelets (co-components) were manufactured by (b)(6) region - 1 co-component was transfused in (b)(6) region hospital without incident and 1 co-component was shipped to (b)(6) region and transfused in a (b)(6) hospital which reported the transfusion reaction.
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An amicus platelet collection was completed on (b)(6) 2020 with amicus disposable kit product code 4r2354, lot fa20d28132 (manufactured in the fresenius kabi haina plant) and intersol product code x6b7850, lot fm20d23042 (manufactured in the fresenius kabi maricao plant).The collection was completed by great lakes region.Two platelet products (co-components) were manufactured by central ohio region.One platelet co-component was transfused in central ohio region hospital with no reaction and one platelet co-component was shipped to penn jersey region.Bact testing was negative after 5 days.On (b)(6) 2020 the co-component was transfused in a (b)(6) hospital where a reaction was reported.On (b)(6) 2020, patient post transfusion culture and residual product cultures were positive for acinetobacter haemolyticus.This was not a fatality.As of 04/28/2021, no additional donor response complaints have been received for amicus disposable kit product code 4r2354, lot fa20d28132 or intersol product code x6b7850, lot fm20d23042.Amicus disposable kit product code 4r2354, lot fa20d28132 used the following solution lots manufactured in the fresenius kabi maricao plant: acda solution lot: fm20c26047 and fm20c11049.Nacl solution lot: fm20c20040 and fm20c24042.One amicus kit was returned by the customer for evaluation.Visual observation found no abnormalities in the perimeter seal of the container or along the top seal area around the ports.There are several light scuff marks noted on both sides of the container indicating that the container slid across something causing these abrasions.The abrasions are on the surface of the plastic sheeting and are not very deep into the plastic.A small cut with a surrounding abrasion was found on the front side (label side) of the container between the central and right top ports and approximately 3/8" below the top seal bead.A small amount of dried plasma is on the cut and abrasion.The abrasion area is approximately 2.25mm x 0.75mm in size.The dried plasma was removed by rinsing with water and wiping with a paper towel.An underwater leak test was performed with the following steps: (1)the container was placed in a restraining fixture to prevent overexpansion during pressurization, (2)the air pressure source was connected to the tubing attached to the top of the container; the air pressure was connected to a dpm (fluke dmp2plus, sn (b)(6) , calibration due 03/04/2021) before being connected to the container, (3)the restraining fixture was placed in a water bath, (4)air pressure was slowly introduced into the container to check for leaks by observing for bubbles.At approximately 0.92 psi air bubbles began slowly emerging from the area of abrasion.The customer complaint is confirmed.The probable root cause could not be determined.A cut on the front panel of the container just below the top ports is the source of the leak.It is unknown how the cut was made on the container, but it is unlikely related to the sealing or manufacture of the container.It is possible that handling after manufacture is the primary contributor of the defect.Batch review: the batch record was reviewed for the amicus disposable kit product code 4r2354, lot fa20d28132.No exceptions were generated that could classify as a possible root cause of the reported issue.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Additionally, a batch review was performed for intersol product code x6b7850, lot fm20d23042.The bioburden test results of this batch were evaluated, and no microorganisms were recovered.Both haina and maricao flora recoveries were reviewed.Maricao uses filling line #4 for all amicus products, including lntersol.Acinetobacter haemolyticus was not found in the maricao plant flora during 2019 or 2020.Haina has had no flora recoveries with the associated bacteria during 2019 or 2020.Based on complaint records, there are no other adverse events reported against the same amicus lot as well as any other code/lot that used the same lots of solutions (naci, acda.And lntersol).Haina and maricao have not found the specific type of bacteria on the amicus process lines and equipment.Amicus has the ability to collect a double platelet procedure.For the donation in question a double product was collected.The second (referred to as co-product) was transfused to a patient with no reaction.If the amicus kit (and/or) solutions were the source of the bacterial contamination, it would have been expected that all platelet product collected be contaminated.
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