| 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 07/02/2021 |
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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) health system hope center reported that a patient had a septic 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) female diagnosed with gliosarcoma in (b)(6) 2021, followed at (b)(6) neuro-oncology.The patient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) health system hope center.The patient developed an acute onset fever (to 40.8c), nausea/vomiting, dyspnea and wheezing while at the clinic and was subsequently sent to the emergency department (ed) at (b)(6).At augusta hospital, she was noted to be in acute respiratory failure with hypoxia which required oxygen supplementation, hypotensive with a mean arterial pressure of less than 65 mm hg, and she was acutely disoriented.Labs revealed lactic acidosis 5.8 mmol/l, neutropenia with wbc count 0.5k/ul, thrombocytopenia 27k/ul.Blood cultures were obtained.The patient was admitted to the (b)(6) hospital icu on (b)(6) 2021 with the diagnosis of septic shock and treated with vancomycin and meropenem.She was also started on low-dose peripheral vasopressors.Her treatment included stress dose steroids with hydrocortisone, as she was functionally adrenally suppressed on chronic dexamethasone for her recurrent gliosarcoma.By (b)(6) 2021, the patient was feeling much better.Surveillance blood cultures obtained on (b)(6) 2021 showed no growth.At some point, the patient was moved out of the icu onto a regular acute care floor (timing unavailable).An infectious disease (id) physician consult obtained on (b)(6) 2021 stated that the patient was doing very well and recommended that the patient be kept inpatient while finishing iv antibiotics.Given the patient's existing comorbidities (myasthenia; thrombocytopenia) id physician recommended against oral antibiotics, or iv antibiotics as an outpatient.The exact date of discharge was not documented in the notes sent by (b)(6) to (b)(6).It is presumed that the date of discharge from (b)(6) was (b)(6) 2021, or soon after.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) health science center and the patient did not have any reaction.The plasma product was discarded for unknown reasons.Background: (b)(4).Location: (b)(6) health system (b)(6) center.Platelet collection date: (b)(6) 2021.Platelet transfusion date: (b)(6) 2021.Pas treated: yes.Intercept treated: yes.Bacteria detected: platelet bag: coagulase negative staphylococcus (confirmed to be staphylococcus saprophyticus) leclercia adecarboxylata enterobacter species (possibly e.Cancerogenus by 16s sequencing) (initially, identified this bacterial isolate as leclercia; recategorized as enterobacter after 16s sequencing) patient blood culture: enterobacter species (possibly e.Cancerogenus by 16s sequencing) (initially, mass spectrometry identified this bacterial isolate as leclercia; it was recategorized as enterobacter species co-product(s): the second platelet unit from the collection was transfused at (b)(6) health science center with no reaction; 1 plasma product from the collection was discarded for unknown reasons.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly amicus code: 4r2354g amicus lot: fa21e03172 final manufacturing: (b)(4).Acda solution lot: fm21d30046 and fm21d20039 (there were 2 lots of acd-a solution that were used in amicus disposable kit lot fa21e03172) naci solution lot: fm21d21045 and fm21e01010 (there were 2 lots of nacl solution that were used in amicus disposable kit lot fa21e03172) solution manufacturing: (b)(4).Intersol (pas) product information: product description: intersol solution platelet additive solution 3 lntersol code: 6b7880 intersol lot: fm21d28032 final assembly: (b)(4).Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets lntercept code/model: int2130b lntercept lot: ce20h20l71 registered manufacturer: cerus corporation, (b)(4).Investigation: code 4r2354g, lot fa21e03172 used the following solution lots: acda solution lot: fm21d30046 and fm21d20039.Nacl solution lot: fm21d21045 and fm21e01010.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lots fm21d30046 and fm21d20039 or nacl solution lots fm21d21045 and fm21e01010.Subsequently, reported complaints on the traced fg lots as of 10/21/2021 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21e03172 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21e03172) of (b)(4) kits were distributed to the (b)(6) of (b)(6) 2021 both (b)(4) recoveries were reviewed: (b)(4): enterobacter species was recovered two (2) times in 2021.There were no recoveries in (b)(6) 2021 (when this lot was manufactured).Enterobacter cancerogenus was not recovered in the (b)(4) plant (b)(4) during 2021.Leclercia adecarboxylata was recovered one (1) time in 2021.This recovery was not in (b)(6) 2021 (when this lot was manufactured).Staphylococcus saprophyticus was recovered in 2021.In (b)(6) 2021 (when this lot was manufactured) there was one recovery; however, it was not recovered on the amicus production line.(b)(4) uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Enterobacter species have been recovered in (b)(4) plant in 2020 and 2021.While these recoveries in 2021 were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4, they were found after the manufacturing of these solutions (within a week) and a capa investigation was initiated to further investigate the source of the organism.Enterobacter cancerogenus was not recovered in the (b)(4) during 2020 or 2021.Leclercia adecarboxylata was recovered two (2) times in the (b)(4) during 2020 in the solution bioburden test of the filling clean room 4; however, this recovery was not during the manufacturing of the solution lots associated with this investigation.It was not recovered in the (b)(4) plant flora during 2021.Staphylococcus saprophyticus has been recovered in (b)(4) normal plant flora.These recoveries were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4.The original platelet collection kit code 4r2354g, lot fa21e03172 was not returned for evaluation.Fresenius (b)(4) summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21e03172 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of haina flora showed that enterobacter species was recovered two (2) times in 2021; however, these recoveries were not identified in may 2021 (when this lot was manufactured).Enterobacter cancerogenus was not recovered in the (b)(4) during 2021.Leclercia adecarboxylata was recovered one (1) time in 2021.This recovery was not in may 2021 (when this lot was manufactured).Staphylococcus saprophyticus was recovered in 2021.In may 2021 (when this lot was manufactured) there was one recovery; however, it was not recovered on the amicus production line.A review of maricao flora showed that enterobacter species, leclercia adecarboxylata, and staphylococcus saprophyticus were recovered, however these recoveries were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4.Enterobacter cancerogenus was not recovered in the (b)(4) during 2020 or 2021.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 being transfused with no reaction, 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 (#3003925919-2021-00003) 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 3003925919-2021-00003: date of event: (b)(6) 2021, date of their report: (b)(6) 2021, on (b)(6) 2021, cerus received a spontaneous serious transfusion reaction report ((b)(4)) of a transfusion transmitted bacterial infection [pt: transmission of an infectious agent via product] from dr.(b)(6), from the (b)(6).Reporter assessment: the reporter assessed the event of a transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] as life threatening in severity and serious due to being life threatening and due to hospitalization.The reporter didn't consider this an expected transfusion reaction that occurred with the transfusion of blood components because the septic reaction after transfusion of pathogen reduced platelet was not an expected event.The causality of the event was reported as certain in relation to intercept treated pc because a rare species of enterobacter was isolated and sequenced from the patient and the bag.The causality was reported as possible in relation to the intercept blood system for platelets device.Cerus medical reviewer concurs with the reporter's assessment that event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] is life threatening in severity and -assesses the event as serious due to hospitalization and being a life-threatening event due to sepsis, treated with antibiotics.The cerus medical reviewer preliminarily assesses causality for the event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] to the intercept-treated pc as possibly related but not related to the intercept blood system for platelets device as the treatment record did not show irregularities in the pr process and a successful illumination of the pc product.At this time, investigations are pending.The cerus reviewer considers this event most likely to be due to post intercept treatment environmental contamination by means of a bag defect, on the basis of the involvement of multiple bacterial strains and the similarity of this event to others that have involved similar strains of bacteria.As the bag was discarded without inspection, his hypothesis cannot be confirmed or ruled out.Intercept treatment has been shown to effectively inactivate s.Saprophyticus and l.Adecarboxylata strains.Pathogen inactivation studies are planned for the implicated enterobacter spp.On receipt from (b)(6).The reviewer notes that intercept treatment was performed in the (b)(6) site.The cerus medical reviewer does not assess the expectedness for the event of transmission of an infectious agent via product due to the lack of information at this time.These assessments will be updated pending updates from arc and further cerus investigations.
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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: university of (b)(6) center reported that a patient had a septic 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 70-year-old female diagnosed with gliosarcoma in (b)(6) 2021, followed at uva neuro-oncology.The patient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) center.The patient developed an acute onset fever (to 40.8c), nausea/vomiting, dyspnea and wheezing while at the clinic and was subsequently sent to the emergency department (ed) at (b)(6) hospital (b)(6).At augusta hospital, she was noted to be in acute respiratory failure with hypoxia which required oxygen supplementation, hypotensive with a mean arterial pressure of less than 65 mm hg, and she was acutely disoriented.Labs revealed lactic acidosis 5.8 mmol/l, neutropenia with wbc count 0.5k/ul, thrombocytopenia 27k/ul.Blood cultures were obtained.The patient was admitted to the (b)(6) hospital icu on (b)(6) 2021 with the diagnosis of septic shock and treated with vancomycin and meropenem.She was also started on low-dose peripheral vasopressors.Her treatment included stress dose steroids with hydrocortisone, as she was functionally adrenally suppressed on chronic dexamethasone for her recurrent gliosarcoma.By (b)(6) 2021, the patient was feeling much better.Surveillance blood cultures obtained on (b)(6) 2021 showed no growth.At some point, the patient was moved out of the icu onto a regular acute care floor (timing unavailable).An infectious disease (id) physician consult obtained on (b)(6) 2021 stated that the patient was doing very well and recommended that the patient be kept inpatient while finishing iv antibiotics.Given the patient's existing comorbidities (myasthenia; thrombocytopenia) id physician recommended against oral antibiotics, or iv antibiotics as an outpatient.The exact date of discharge was not documented in the notes sent by (b)(6)to (b)(6).It is presumed that the date of discharge from (b)(6) was (b)(6) 2021, or soon after.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 uva health science center and the patient did not have any reaction.The plasma product was discarded for unknown reasons.Background: complaint information (b)(4): arc#: (b)(4).Location: university of (b)(6) hope center.Platelet collection date: (b)(6), 2021.Platelet transfusion date: (b)(6), 2021.Pas treated: yes.Intercept treated: yes.Bacteria detected: platelet bag: coagulase negative staphylococcus (confirmed to be staphylococcus saprophyticus).Leclercia adecarboxylata.Enterobacter species (possibly e.Cancerogenous by 16s sequencing) (initially, identified.This bacterial isolate as leclercia; recategorized as enterobacter after 16s sequencing).Patient blood culture: enterobacter species (possibly e.Cancerogenous by 16s sequencing) (initially, mass spectrometry identified this bacterial isolate as leclercia; it was recategorized as enterobacter species.Co-product(s): the second platelet unit from the collection was transfused at (b)(6) center with no reaction; 1 plasma product from the collection was discarded for unknown reasons.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly.Amicus code: 4r2354g.Amicus lot: fa21e03172.Final manufacturing: (b)(6), dr.Acda solution lot: fm21d30046 and fm21d20039 (there were 2 lots of acd-a solution that were used in amicus disposable kit lot fa21e03172).Naci solution lot: fm21d21045 and fm21e01010 (there were 2 lots of nacl solution that were used in amicus disposable kit lot fa21e03172).Solution manufacturing: (b)(6), pr.Intersol (pas) product information: product description: intersol solution platelet additive solution 3.Lntersol code: 6b7880.Intersol lot: fm21d28032.Final assembly: (b)(6), pr.Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets.Lntercept code/model: int2130b.Lntercept lot: ce20h20l71.Registered manufacturer: (b)(6).Investigation: code 4r2354g, lot fa21e03172 used the following solution lots: acda solution lot: fm21d30046 and fm21d20039.Nacl solution lot: fm21d21045 and fm21e01010.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lots fm21d30046 and fm21d20039 or nacl solution lots fm21d21045 and fm21e01010.Subsequently, reported complaints on the traced fg lots as of (b)(6) 2021 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21e03172 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21e03172) of (b)(4) kits were distributed to the american red cross as of (b)(6) 2021.Both (b)(6) recoveries were reviewed: (b)(6): enterobacter species was recovered two (2) times in 2021.There were no recoveries in (b)(6) 2021 (when this lot was manufactured).Enterobacter cancerogenous was not recovered in the (b)(6) during 2021.Leclercia adecarboxylata was recovered one (1) time in 2021.This recovery was not in (b)(6) 2021 (when this lot was manufactured).Staphylococcus saprophyticus was recovered in 2021.In (b)(6) 2021 (when this lot was manufactured) there was one recovery; however, it was not recovered on the amicus production line.(b)(6) uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Enterobacter species have been recovered in (b)(6) plant in 2020 and 2021.While these recoveries in 2021 were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4, they were found after the manufacturing of these solutions (within a week) and a capa investigation was initiated to further investigate the source of the organism.Enterobacter cancerogenous was not recovered in the (b)(6)during 2020 or 2021.Leclercia adecarboxylata was recovered two (2) times in the (b)(6) during 2020 in the solution bioburden test of the filling clean room 4; however, this recovery was not during the manufacturing of the solution lots associated with this investigation.It was not recovered in the (b)(6) during 2021.Staphylococcus saprophyticus has been recovered in (b)(6).These recoveries were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4.The original platelet collection kit code 4r2354g, lot fa21e03172 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21e03172 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of (b)(6) showed that enterobacter species was recovered two (2) times in 2021; however, these recoveries were not identified in (b)(6) 2021 (when this lot was manufactured).Enterobacter cancerogenous was not recovered in the (b)(6) during 2021.Leclercia adecarboxylata was recovered one (1) time in 2021.This recovery was not in (b)(6) 2021 (when this lot was manufactured).Staphylococcus saprophyticus was recovered in 2021.In (b)(6) 2021 (when this lot was manufactured) there was one recovery; however, it was not recovered on the amicus production line.A review of (b)(6) showed that enterobacter species, leclercia adecarboxylata, and staphylococcus saprophyticus were recovered, however these recoveries were not identified during the manufacturing dates of the solution lots involved in this incident in mixing room 2 and filling line 4.Enterobacter cancerogenous was not recovered in the (b)(6) during 2020 or 2021.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 being transfused with no reaction, 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 (#3003925919-2021-00003) 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 3003925919-2021-00003: date of event: (b)(6) 2021, date of their report: (b)(6) 2021, on (b)(6) 2021, cerus received a spontaneous serious transfusion reaction report (b)(4) of a transfusion transmitted bacterial infection [pt: transmission of an infectious agent via product] from dr.(b)(6), from the american red cross (arc) in washington, d.C.Reporter assessment: the reporter assessed the event of a transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] as life threatening in severity and serious due to being life threatening and due to hospitalization.The reporter didn't consider this an expected transfusion reaction that occurred with the transfusion of blood components because the septic reaction after transfusion of pathogen reduced platelet was not an expected event.The causality of the event was reported as certain in relation to intercept treated pc because a rare species of enterobacter was isolated and sequenced from the patient and the bag.The causality was reported as possible in relation to the intercept blood system for platelets device.Cerus medical reviewer concurs with the reporter's assessment that event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] is life threating in severity and -assesses the event as serious due to hospitalization and being a life-threatening event due to sepsis, treated with antibiotics.The cerus medical reviewer preliminarily assesses causality for the event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] to the intercept-treated pc as possibly related but not related to the intercept blood system for platelets device as the treatment record did not show irregularities in the pr process and a successful illumination of the pc product.At this time, investigations are pending.The cerus reviewer considers this event most likely to be due to post intercept treatment environmental contamination by means of a bag defect, on the basis of the involvement of multiple bacterial strains and the similarity of this event to others that have involved similar strains of bacteria.As the bag was discarded without inspection, his hypothesis cannot be confirmed or ruled out.Intercept treatment has been shown to effectively inactivate s.Saprophyticus and l.Adecarboxylata strains.Pathogen inactivation studies are planned for the implicated enterobacter spp.On receipt from uva.The reviewer notes that intercept treatment was performed in the arc columbus oh site.The cerus medical reviewer does not assess the expectedness for the event of transmission of an infectious agent via product due to the lack of information at this time.These assessments will be updated pending updates from arc and further cerus investigations.Follow-up mdr information: update as of 08 feb 2022: fresenius kabi investigation the used amicus kit, batch fa21e03172, was not received from the customer for evaluation.However, fresenius kabi did complete an internal investigation (record # (b)(4)).Microbiological testing results were reviewed with satisfactory results for the amicus kit batch fa21e03172 manufacturing period, including the previous month.The bacteria identified by the customer was not found in the (b)(6) during the manufacturing period of the reported batch.Current controls in place at the (b)(6) manufacturing facility include: o microbiology monitoring, o product e-beam sterilization, o in process sampling quality inspection, and o post sterilization sampling final inspection.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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