| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Sepsis (2067)
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| Event Date 12/31/2021 |
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Event Type
Death
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Event Description
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On (b)(6) 2022, fresenius kabi was notified of a possible recipient reaction.However, no details or product information were provided to fresenius kabi until (b)(6) 2022.At that time, fresenius kabi received the following: recipient information: ucsf health: (b)(4) reported that a recipient had a serious (fatal) reaction after getting a platelet transfusion.The product was collected on (b)(6) 2021 and the transfusion occurred on (b)(6) 2021.Recipient is a (b)(6) male with a primary diagnosis of diffuse large b cell lymphoma.The recipient was transfused with a pathogen-reduced apheresis platelets unit at ucsf health.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, and the recipient did not have any reaction.Background: complaint information ((b)(4)): arc#: (b)(4).Location: ucsf health: (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 recipient's post-transfusion blood cultures.Co-product(s): the second platelet unit from the collection was transfused and there was no reaction.The plasma product was quarantined and sent to uc davis medical center.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly.Amicus code: 4r2354g.Amicus lot: fa21j11226.Final manufacturing: (b)(4).Acda solution lot: fm21i16036 and fm21i23040.Naci solution lot: fm21i27033.Solution manufacturing: (b)(4).Intersol (pas) product information: product description: intersol solution platelet additive solution 3.Lntersol code: 6b7880.Intersol lot: fm21g15032.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: ce21g05l71.Registered manufacturer: (b)(4).Investigation: code 4r2354g, lot fa21j11226 used the following solution lots: acda solution lot: fm21i16036 or fm21i23040.Nacl solution lot: fm21i27033.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lots fm21i16036 or fm21i23040 or nacl solution lot fm21i27033.Subsequently, reported complaints on the traced fg lots as of (b)(6) 2022 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21j11226 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21j11226) of (b)(4) kits were distributed to the american red cross as of (b)(6) 2021.Both (b)(4) recoveries were reviewed: (b)(4): acinetobacter baumannii was recovered two (2) times between (b)(6) 2021 and (b)(6) 2021.These recoveries were 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 four recoveries of other acinetobacter species.Three were unrelated to the amicus product.However, one of the recoveries in (b)(6) 2021 was in clean room 2, which is related to the amicus product.(b)(4) uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Acinetobacter baumannii was not recovered in the (b)(4) manufacturing plant in 2021.The original platelet collection kit code 4r2354g, lot fa21j11226 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21j11226 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of (b)(6) 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.A review of (b)(6) showed that acinetobacter baumannii was not recovered in 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 recipient 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 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 (#3003925919-2022-00001) for the intercept platelet storage container that is used after amicus platelet storage and contains additional details of the investigation.According to cerus medwatch 3003925919-2022-00001: date of event: (b)(6) 2021, date of their report: (b)(6) 2022, cerus reported they received a spontaneous serious (fatal) transfusion reaction report ((b)(4)) of a suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] from dr.(b)(6), the executive vice president, chief medical & scientific officer at vitalant blood services.Vitalant blood services received a report from the university of (b)(4) (ucsf) and was asked to investigate a patient's death that occurred at the ucsf over the christmas/new year break (2021-2022).The initial report alerted cerus of a possible transfusion reaction in a patient, involving an intercept treated platelet concentrate (pc) (din #(b)(4), set lot #ce21g05l71, product code: int2230b) transfused at ucsf that was prepared at the american red cross blood services (arc).Reporter assessment: the reporter assessed the event of suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] as fatal in severity and serious due to death.The reporter considered the causality for the event to be possible in relation to the transfused intercept platelets and to intercept blood system for platelets.The reporter's rationale was reported as "acinetobacter species had recently been identified as a pathogen of concern in apheresis platelet units (fda communication, (b)(6) 2021)".This is addressed in the mr assessment-below.Cerus medical review assessment: cerus medical reviewer agrees with the reporters assessment that event of suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] is fatal in severity and serious due to death.The medical reviewer notes that this patient was admitted from another facility already in a septic state with a decubitus ulcer that may have been infected at the time of admission.The transmitting hospital was apparently known to have an outbreak of antibiotic resistant acbc bacterial strains.No transfusion reactions were noted at the time of platelet transfusion and no investigations were performed to detect contamination of the platelet products or evidence of bag defects that might have led to contamination.The manufacture of the intercept platelets is still under investigation to confirm that all processes were performed according to protocol.Co-components manufactured from the same platelet donations were transfused without incident.At this time, there was no evidence that the intercept platelets were involved in a transfusion reaction, other than the incidental notification from the fda of a case series of platelet transfusions that were contaminated with acbc bacteria in multiple institutions around the us over the last 3 years, including ucsf in 2018.These cases all involved a common strain of acbc that was known to be highly sensitive to antibiotics.In the case described in this narrative, the acbc strain was highly resistant to antibiotics and therefore phenotypically different from the prior strains mentioned in the fda report.Based on these findings, cerus concludes that there was no evidence supporting a causal relationship to the transfused intercept platelets or the intercept blood system for platelets device.In spite of the temporal relationship with the implicated intercept platelet transfusion, the medical reviewer believed that this was a coincidence with the patient dying from sepsis that required platelet transfusions for thrombocytopenia, and not as a result of the intercept platelet transfusions.
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Event Description
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On (b)(6) 2022, fresenius kabi was notified of a possible recipient reaction.However, no details or product information were provided to fresenius kabi until (b)(6) 2022.At that time, fresenius kabi received the following: recipient information: (b)(6): (b)(6) reported that a recipient had a serious (fatal) reaction after getting a platelet transfusion.The product was collected on (b)(6) 2021 and the transfusion occurred on (b)(6) 2021.Recipient is a (b)(6) male with a primary diagnosis of diffuse large b cell lymphoma.The recipient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6).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, and the recipient did not have any reaction.Background: complaint information ((b)(4)): arc#: (b)(4).Location: (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 recipient's post-transfusion blood cultures.Co-product(s): the second platelet unit from the collection was transfused and there was no reaction.The plasma product was quarantined and sent to uc davis medical center.Amicus product information: product description: amicus double needle advanced disposable kit with 20ml platelet sampling system assembly.Amicus code: 4r2354g.Amicus lot: fa21j11226.Final manufacturing: (b)(4).Acda solution lot: fm21i16036 and fm21i23040.Naci solution lot: fm21i27033.Solution manufacturing: (b)(4).Intersol (pas) product information: product description: intersol solution platelet additive solution 3.Lntersol code: 6b7880.Intersol lot: fm21g15032.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: ce21g05l71.Registered manufacturer: (b)(4).Investigation: code 4r2354g, lot fa21j11226 used the following solution lots: acda solution lot: fm21i16036 or fm21i23040.Nacl solution lot: fm21i27033.A batch traceability (finished good (fg) lot) was performed to trace an amicus fg that used acda solution lots fm21i16036 or fm21i23040 or nacl solution lot fm21i27033.Subsequently, reported complaints on the traced fg lots as of (b)(6) 2022 were reviewed.Based on complaint records, there are no additional adverse events reported against amicus lot fa21j11226 or any fg lot that used the same lots of solutions (nacl or acda).The entire lot (fa21j11226) of (b)(4) kits were distributed to the american red cross as of (b)(6) 2021.Both (b)(4) recoveries were reviewed: (b)(4): acinetobacter baumannii was recovered two (2) times between (b)(6) 2021 and (b)(6) 2021.These recoveries were 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 four recoveries of other acinetobacter species.Three were unrelated to the amicus product.However, one of the recoveries in (b)(6) 2021 was in clean room 2, which is related to the amicus product.(b)(4) uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Acinetobacter baumannii was not recovered in the (b)(4) manufacturing plant in 2021.The original platelet collection kit code 4r2354g, lot fa21j11226 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot fa21j11226 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of (b)(6) 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.A review of (b)(6) showed that acinetobacter baumannii was not recovered in 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 recipient 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 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 (#3003925919-2022-00001) for the intercept platelet storage container that is used after amicus platelet storage and contains additional details of the investigation.According to cerus medwatch 3003925919-2022-00001: date of event: (b)(6) 2021, date of their report: (b)(6) 2022, cerus reported they received a spontaneous serious (fatal) transfusion reaction report ((b)(4)) of a suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] from dr.(b)(6), the executive vice president, chief medical & scientific officer at vitalant blood services.Vitalant blood services received a report from the (b)(6) and was asked to investigate a patient's death that occurred at the (b)(6) over the christmas/new year break (2021-2022).The initial report alerted cerus of a possible transfusion reaction in a patient, involving an intercept treated platelet concentrate (pc) (din #(b)(4), set lot #ce21g05l71, product code: int2230b) transfused at (b)(6) that was prepared at the american red cross blood services (arc).Reporter assessment: the reporter assessed the event of suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] as fatal in severity and serious due to death.The reporter considered the causality for the event to be possible in relation to the transfused intercept platelets and to intercept blood system for platelets.The reporter's rationale was reported as "acinetobacter species had recently been identified as a pathogen of concern in apheresis platelet units (fda communication, (b)(6) 2021)".This is addressed in the mr assessment-below.Cerus medical review assessment: cerus medical reviewer agrees with the reporters assessment that event of suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] is fatal in severity and serious due to death.The medical reviewer notes that this patient was admitted from another facility already in a septic state with a decubitus ulcer that may have been infected at the time of admission.The transmitting hospital was apparently known to have an outbreak of antibiotic resistant acbc bacterial strains.No transfusion reactions were noted at the time of platelet transfusion and no investigations were performed to detect contamination of the platelet products or evidence of bag defects that might have led to contamination.The manufacture of the intercept platelets is still under investigation to confirm that all processes were performed according to protocol.Co-components manufactured from the same platelet donations were transfused without incident.At this time, there was no evidence that the intercept platelets were involved in a transfusion reaction, other than the incidental notification from the fda of a case series of platelet transfusions that were contaminated with acbc bacteria in multiple institutions around the us over the last 3 years, including (b)(6) in 2018.These cases all involved a common strain of acbc that was known to be highly sensitive to antibiotics.In the case described in this narrative, the acbc strain was highly resistant to antibiotics and therefore phenotypically different from the prior strains mentioned in the fda report.Based on these findings, cerus concludes that there was no evidence supporting a causal relationship to the transfused intercept platelets or the intercept blood system for platelets device.In spite of the temporal relationship with the implicated intercept platelet transfusion, the medical reviewer believed that this was a coincidence with the patient dying from sepsis that required platelet transfusions for thrombocytopenia, and not as a result of the intercept platelet transfusions.
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Event Description
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On april 13, 2022, fresenius kabi received updated investigation information from cerus for the reported spontaneous serious (fatal) transfusion reaction report, medwatch 3003925919-2022-00001.According to cerus follow-up medwatch 3003925919-2022-00001: updates to reporters assessment: the reporter considered the causality for the event to be possible in relation to the transfused intercept platelets and to intercept blood system for platelets as per original frm 00785, however, all subsequent updates indicate that intercept platelets were, subsequently, not considered implicated.The reporter's rationale was reported as: "per communication from (b)(6) [(b)(6) department of public health] to our hospital infection control team, wgs [whole genome sequencing] matched the other stanislaus county case who was hospitalized at another local hospital.Both cases were imported and were hospitalized at the same hospital in (b)(6) as our patient.As noted earlier, there have been some outbreaks in different facilities in (b)(6).Based on the above information, we have conclusively ruled out platelets as a source of contamination and conclude our investigation of this case." updates to cerus medical review assessment: in the case described in this narrative, the acbc strain was highly resistant to antibiotics and, therefore, phenotypically different from the prior strains mentioned in the fda report.The statement from dr.Nambiar-above, based on arc investigation, supports this conclusion that the patient was transferred to the transfusing hospital with a nosocomial acinetobacter infection with a strain independent from the prior implicated strains from cases of contaminated intercept platelets.Based on these findings, cerus concludes that there was no evidence supporting a causal relationship of the event to the transfused intercept platelets or the intercept blood system for platelets device.In spite of the temporal relationship with the implicated intercept platelet transfusion, the medical reviewer believes that this was a coincidence with the patient dying from sepsis that required platelet transfusions for thrombocytopenia and other complications, and not as a result of the intercept platelet transfusions.As documented within fresenius kabi's initial medwatch 3004548776-2022-00026, "fresenius-kabi's investigation has found that there is no direct correlation between the plant flora and the bacteria from this incident".Therefore, fresenius kabi concurs with the cerus conclusion that there was no evidence supporting a causal relationship of the event to the transfused platelets.
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