| Model Number N/A |
| Device Problem
Appropriate Term/Code Not Available (3191)
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| Patient Problem
Sepsis (2067)
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| Event Date 08/17/2021 |
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Event Type
Injury
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Event Description
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On 9/23/2021, fresenius (b)(4) was notified of the following: patient information: (b)(6) hospital reported that a patient had a reaction after getting a platelet transfusion.The product was collected on (b)(6) 2021 and the transfusion occurred on (b)(6) 2021.Patient is a (b)(6) male with a primary diagnosis of acute myelomonocytic leukemia status post chemotherapy and neutropenic fevers.The patient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) hospital.The patient's temperature increased from baseline (99.0 f to 101.0 f) 15 minutes after platelet transfusion and fell to 98.4 f after transfusion.No other symptoms or changes in vital signs were noted.Product information (as provided by (b)(6) the product was collected on amicus as a double platelet product collection with intersol.The final storage container was from a cerus kit.The co-product platelet product was transfused at (b)(6) hospital and the patient did not have any reaction.Background: (b)(4).Location: (b)(6) hospital in (b)(6).Platelet collection date: (b)(6) 2021.Platelet transfusion date: (b)(6) 2021.Pas treated: yes.Intercept treated: yes.Bacteria detected: acinetobacter baumannii: found in the platelet product and bacillus species not anthracis: found in platelet product co-product(s): the second platelet unit from the collection was transfused at edward w.Sparrow hospital and there was no reaction.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly amicus code: 4r2354g, amicus lot: fa21f14169, final manufacturing: (b)(4), acda solution lot: fm21f05019, naci solution lot: fm21f03048, solution manufacturing: (b)(4).Intersol (pas) product information: product description: intersol solution platelet additive solution 3, lntersol code: 6b7880, intersol lot: fm21f11033, final assembly: (b)(4).Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets, lntercept code/model: int2230b, lntercept lot: ce21d02l71, registered manufacturer: cerus corporation, (b)(4) usa.Investigation: code 4r2354g, lot fa21f14169 used the following solution lots: acda solution lot: fm21f05019, nacl solution lot: fm21f03048.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lot fm21f05019 or nacl solution lot fm21f03048.Subsequently, reported complaints on the traced fg lots as of 10/20/2021 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21f14169 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21f14169) of 2,118 kits were distributed to the (b)(6) as of 08/05/2021.Both (b)(4) recoveries were reviewed: (b)(4): acinetobacter baumannii was recovered one (1) time in 2021.This recovery was not in (b)(6) 2021 (when this lot was manufactured).Other acinetobacter species have been recovered in 2021.In (b)(6) 2021 (when this lot was manufactured) there were two recoveries of other acinetobacter species.One was unrelated to the amicus product.However, one recovery was in clean room 2.Bacillus species not anthracis was recovered in 2021.However, there were no recoveries in (b)(6) 2021 (when this lot was manufactured).(b)(4) uses (b)(4) for all amicus solutions, including intersol.Acinetobacter baumannii was recovered five (5) times in 2020: one (1) time in a surface test, one (1) time in a room air test and three (3) times in water tests; no recoveries were reported in the solution bioburden and device bioburden tests.One (1) of the five (5) instances was the floor of change room for mixing #2; however, this recovery was not during the manufacturing of the solution lots associated with this investigation.Bacillus species not anthracis - plant flora investigation is still under review and will be included in the follow up mdr the original platelet collection kit code 4r2354g, lot fa21f14169 was not returned for evaluation.Fresenius (b)(4) summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21f14169 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of (b)(4) flora showed that acinetobacter baumannii was recovered, however the recovery was identified outside of the manufacturing date of the fg lot involved in this incident.Other acinetobacter species have been recovered in 2021.One recovery was during the manufacturing month of (b)(6) 2021 when this lot was manufactured and was found in clean room 2.The review also showed that bacillus species not anthracis was recovered in 2021.However, no recoveries occurred during the manufacturing of the fg lot associated with this investigation.A review of maricao flora showed that acinetobacter baumannii was recovered, however these recoveries were identified outside of the manufacturing dates of the solution lots involved in this incident.The amicus disposable kit used in this procedure allowed for a double platelet product (2 bags) to be collected.The second (referred to as co-product) was transfused to a patient with no reaction.Based on the knowledge of how the product is used in the field and the co-product testing negative for bacteria, fresenius-(b)(4) preliminary investigation has found that there is no direct correlation between the plant flora and the bacteria from this incident.As an additional note: cerus corporation submitted a medwatch (#3003925919-2021-00005) for the intercept platelet storage container that is used after amicus platelet storage and contains another part of the comprehensive investigation.According to cerus medwatch 3003925919-2021-00005: date of event: (b)(6) 2021, date of their report: 01-oct-2021, cerus reported their case of a non-serious adverse event because of similar cases involving environmental bacterial contamination of platelet components that had been successfully treated with the intercept blood system for platelets.The cerus medical review assessment concluded the following: from the clinical presentation (one-time temperature increase with no further signs or symptoms of infection) and the microbiology findings (patient's pre- and post-transfusion negative blood cultures), cerus medical reviewer considered the described event to be a mild and non-serious febrile non-hemolytic transfusion reaction (fnhtr) in a neutropenic patient after chemotherapy treatment, with underlying ongoing neutropenic fevers, and not a ttbi.The cerus medical reviewer considers the causality of the event of fnhtr to be possible in relation to intercept pc, however, not related to intercept blood system for platelets device, which, based on the treatment records, performed as designed.A lack of patient blood culture positivity and lack of clinical manifestation of a septic episode, together with an intercept co-component transfusion to another patient without a transfusion reaction, does not support an intercept blood system for platelets device-related ttbi.The gram stain of the product post transfusion was negative, implying a low or non-existent concentration of bacteria.A contamination post intercept treatment of the pc is suspected.A breach in integrity of the pc bag most likely occurred at the time of transfusion during preparation of the transfusion set by excessive force from a cannula spike through the port, that contaminated the pc but did not cause a ttbi.Proliferation of the bacteria in the few hours after spiking until the time of sampling probably gave rise to the positive bag cultures.This hypothesis is in keeping with other reported septic transfusion cases that implicated post intercept contamination of pcs from the surface of the platelet bag into the container through breeches in the integrity of the container.
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Event Description
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Initial mdr information: on 9/23/2021, fresenius kabi was notified of the following: patient information: (b)(6) hospital reported that a patient had a reaction after getting a platelet transfusion.The product was collected on (b)(6) 2021 and the transfusion occurred on (b)(6) 2021.Patient is a 65-year-old male with a primary diagnosis of acute myelomonocytic leukemia status post chemotherapy and neutropenic fevers.The patient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) hospital.The patient's temperature increased from baseline (99.0 f to 101.0 f) 15 minutes after platelet transfusion and fell to 98.4 f after transfusion.No other symptoms or changes in vital signs were noted.Product information (as provided by american red cross (arc)): the product was collected on amicus as a double platelet product collection with intersol.The final storage container was from a cerus kit.The co-product platelet product was transfused at (b)(6) hospital and the patient did not have any reaction.Background: complaint information (b)(4): location: (b)(6) hospital in (b)(6).Platelet collection date: (b)(6) 2021.Platelet transfusion date: (b)(6) 2021.Pas treated: yes.Intercept treated: yes.Bacteria detected: acinetobacter baumannii: found in the platelet product and bacillus species not anthracis: found in platelet product co-product(s): the second platelet unit from the collection was transfused at (b)(6) hospital and there was no reaction.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly.Amicus code: 4r2354g, amicus lot: fa21f14169, final manufacturing: haina, dr, acda solution lot: fm21f05019, naci solution lot: fm21f03048, solution manufacturing: maricao, pr.Intersol (pas) product information: product description: intersol solution platelet additive solution 3, lntersol code: 6b7880, intersol lot: fm21f11033, final assembly: maricao, pr.Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets, lntercept code/model: int2230b, lntercept lot: ce21d02l71, registered manufacturer: cerus corporation, 1220 concord, ave, concord ca, 94520, usa.Investigation: code 4r2354g, lot fa21f14169 used the following solution lots: acda solution lot: fm21f05019, nacl solution lot: fm21f03048.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lot fm21f05019 or nacl solution lot fm21f03048.Subsequently, reported complaints on the traced fg lots as of 10/20/2021 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21f14169 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21f14169) of (b)(4) were distributed to the american red cross as of 08/05/2021.Both haina and maricao flora recoveries were reviewed: haina: acinetobacter baumannii was recovered one (1) time in 2021.This recovery was not in june 2021 (when this lot was manufactured).Other acinetobacter species have been recovered in 2021.In june 2021 (when this lot was manufactured) there were two recoveries of other acinetobacter species.One was unrelated to the amicus product.However, one recovery was in clean room 2.Bacillus species not anthracis was recovered in 2021.However, there were no recoveries in june 2021 (when this lot was manufactured).Maricao uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Acinetobacter baumannii was recovered five (5) times in 2020: one (1) time in a surface test, one (1) time in a room air test and three (3) times in water tests; no recoveries were reported in the solution bioburden and device bioburden tests.One (1) of the five (5) instances was the floor of change room for mixing #2; however, this recovery was not during the manufacturing of the solution lots associated with this investigation.Bacillus species not anthracis - plant flora investigation is still under review and will be included in the follow up mdr.The original platelet collection kit code 4r2354g, lot fa21f14169 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21f14169 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of haina flora showed that acinetobacter baumannii was recovered, however the recovery was identified outside of the manufacturing date of the fg lot involved in this incident.Other acinetobacter species have been recovered in 2021.One recovery was during the manufacturing month of june 2021 when this lot was manufactured and was found in clean room 2.The review also showed that bacillus species not anthracis was recovered in 2021.However, no recoveries occurred during the manufacturing of the fg lot associated with this investigation.A review of maricao flora showed that acinetobacter baumannii was recovered, however these recoveries were identified outside of the manufacturing dates of the solution lots involved in this incident.The amicus disposable kit used in this procedure allowed for a double platelet product (2 bags) to be collected.The second (referred to as co-product) was transfused to a patient with no reaction.Based on the knowledge of how the product is used in the field and the co-product testing negative for bacteria, fresenius-kabi's preliminary investigation has found that there is no direct correlation between the plant flora and the bacteria from this incident.As an additional note: cerus corporation submitted a medwatch (#3003925919-2021-00005) for the intercept platelet storage container that is used after amicus platelet storage and contains another part of the comprehensive investigation.According to cerus medwatch 3003925919-2021-00005: date of event: (b)(6) 2021, date of their report: 01-oct-2021, cerus reported their case of a non-serious adverse event because of similar cases involving environmental bacterial contamination of platelet components that had been successfully treated with the intercept blood system for platelets.The cerus medical review assessment concluded the following: from the clinical presentation (one-time temperature increase with no further signs or symptoms of infection) and the microbiology findings (patient's pre- and post-transfusion negative blood cultures), cerus medical reviewer considered the described event to be a mild and non-serious febrile non-hemolytic transfusion reaction (fnhtr) in a neutropenic patient after chemotherapy treatment, with underlying ongoing neutropenic fevers, and not a ttbi.The cerus medical reviewer considers the causality of the event of fnhtr to be possible in relation to intercept pc, however, not related to intercept blood system for platelets device, which, based on the treatment records, performed as designed.A lack of patient blood culture positivity and lack of clinical manifestation of a septic episode, together with an intercept co-component transfusion to another patient without a transfusion reaction, does not support an intercept blood system for platelets device-related ttbi.The gram stain of the product post transfusion was negative, implying a low or nonexistent concentration of bacteria.A contamination post intercept treatment of the pc is suspected.A breach in integrity of the pc bag most likely occurred at the time of transfusion during preparation of the transfusion set by excessive force from a cannula spike through the port, that contaminated the pc but did not cause a ttbi.Proliferation of the bacteria in the few hours after spiking until the time of sampling probably gave rise to the positive bag cultures.This hypothesis is in keeping with other reported septic transfusion cases that implicated post intercept contamination of pcs from the surface of the platelet bag into the container through breeches in the integrity of the container.Follow-up mdr information: update as of 08 feb 2022: fresenius kabi investigation: the used amicus kit, batch fa21f14169, was not received from the customer for evaluation.However, fresenius kabi did complete an internal investigation ((b)(4)).Microbiological testing results were reviewed with satisfactory results for the amicus kit batch fa21f14169 manufacturing period, including the previous month.The bacteria identified by the customer was not found in the haina plant micro-flora during the manufacturing period of the reported batch.Current controls in place at the haina manufacturing facility include: microbiology monitoring, product e-beam sterilization, in process sampling quality inspection, and post sterilization sampling final inspection.Maricao flora: based on the data evaluated, an adverse trend was identified during the year 2020 with the acinetbacter sp.Organisms recovered in the maricao plant flora.After evaluation of the data by organism, a.Baumannii was recovered during 2020 but these recoveries did not represent an adverse trend for acinetobacter sp.As part of the septic transfusion reaction complaint assessment, the disinfectant efficacy study and growth promotion test study needed to be performed with the a.Baumannii organisms.The growth promotion test was performed and the final report was completed in december 2021.The study demonstrated that media used in maricao is capable of recovering the organisms associated with the reported complaint.The disinfection efficacy study is scheduled to be completed by the end of (b)(6) 2022 by a third-party lab.Acinetobacter is trending downward after the implementation of sporicidal disinfectant in the production areas in late 2019 and the qualification of the new chlorination system that chlorinates the city water used in the handwashers located in the production areas at the maricao plant.The chlorination system is installed in the manufacturing area and is in service for water used for washing hands.Since (b)(6) 2021, this system is in the last phase of the validation process that monitors the effectiveness of the system through seasonal fluctuations.Initial phases of the validation were executed and have obtained satisfactory results.Based on the data evaluated for bacillus sp., the microorganism is commonly recovered as part of the maricao plant flora.Although an increase was identified from (b)(6) 2020 to (b)(6) 2021, the recoveries were identified in the laboratory areas and the bioburden test performed with the blood pack unit filter and not in the amicus product (the product associated with the reported complaint).Per the applicable specification, the thermal death study was performed with the positive bacillus recovered in the surface tests and in the bioburden test.The thermal death study is a regular test performed every time a positive bacillus (spore former) is recovered to determine how much the organism is resistant to heat.If the organisms survive this test, then a comparison evaluation is performed to determine if the organism could survive maricao's moist heat sterilization process.This comparison is performed with the bacteriological indicator used to challenge maricao's sterilization cycles.The positive bacillus did not survive the study confirming that it would not survive maricao's sterilization cycle.As part of internal growth promotion tests and the efficacy study, the commonly positive bacillus is used to perform the tests and after implementation of sporicidal in late 2019, trending showed a decrease in recoveries in the bioburden test to the filter and in the laboratory areas.The frequency was established first every six months and it was later changed in 2020 to every three months.Based on the knowledge of how the product is used in the field and the co-product testing negative for bacteria, fresenius-kabi's investigation has found that there is no direct correlation between the plant flora and the bacteria from this incident.
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