| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Fever (1858)
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| Event Date 08/15/2022 |
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Event Type
Injury
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Event Description
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On 9/18/2022, fresenius kabi was notified of a possible recipient reaction: recipient information: (b)(6) university hospital reported a recipient reaction after receiving a platelet transfusion.The product was collected on (b)(6) 2022 and the transfusion occurred on (b)(6) 2022.Recipient was a 21-year-old male with a primary diagnosis of acute myeloid leukemia.The recipient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) university hospital.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 there was no recipient reaction.Background: complaint information (b)(4): arc#: dcsc-p-053-tr-sep06591.Location: (b)(6) university hospital.Platelet collection date: (b)(6) 2022.Platelet transfusion date: (b)(6) 2022.Pas treated: yes.Intercept treated: yes.Bacteria detected: bacillus circulans: found in the platelet bag.Co-product(s): the second platelet unit from the collection was transfused at children's hospital of philadelphia and there was no reaction.The plasma product was quarantined.Amicus product information: product description: amicus double needle advanced kit with platelet additive solution connector amicus code: 4r2352.Amicus lot: fa22e30158.Final manufacturing: (b)(4) dr.Acda solution lot: fm22e31032.Naci solution lot: fm22f01033.Solution manufacturing: (b)(4) pr.Intersol (pas) product information: product description: intersol solution platelet additive solution 3 lntersol code: 6b7880, intersol lot: fm22f11016, final assembly: (b)(4) pr.Cerus corporations intercept platelet storage container product information: product description: intercept blood system for platelets lntercept code/model: int2230b.Lntercept lot: ce22b04l71.Registered manufacturer:(b)(4) usa.Investigation: code 4r2352, lot fa22e30158 used the following solution lots: acda solution lot: fm22e31032.Nacl solution lot: fm22f01033.A batch traceability (finished good (fg) lot) was performed to trace other amicus codes that used these solutions:· reported complaints on the above fg lots as of 10/12/2022 are as follows: the entire lot (fa22e30158) of 2,283 kits were distributed to the american red cross as of 8/3/2022.Both (b)(6) recoveries were reviewed: haina: bacillus circulans was not recovered in the microbiology monitoring performed from january 2019 through may 2022.The fg lot was manufactured in may 2022.Bacillus circulans was recovered one (1) time in june 2022.The recovery was the month after the fg lot was manufactured.The recovery was not found in any area that amicus is manufactured in.Maricao uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Bacillus circulans was recovered one (1) time in january 2022.The recovery was not in may or june 2022 when the solutions lots were manufactured.The recovery was not found in mixing room 2 or filling line 4.The original platelet collection kit code 4r2352, lot fa22e30158 was not returned for evaluation.(b)(6) summary: based on complaint records, there are no additional adverse events reported against amicus lot fa22e30158 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of haina flora showed that bacillus circulans was recovered, however the recovery was identified outside of the manufacturing date of the fg lot involved in this incident.A review of maricao flora showed that bacillus circulans was recovered, however the recovery was identified outside of the manufacturing date of the solution lots involved in this incident and not in the clean room where the amicus and intersol solutions are manufactured.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.No conclusion has been determined at this time.The investigation continues and any additional information will be provided in a update to the mdr.Additional information received by (b)(6) from the american red cross: patient was a 21-year-old male being treated for acute myeloid leukemia had a transfusion reaction to platelet unit (b)(4).The transfusion was started at 12:55 on (b)(4) 2022 and was marked by an increase in body temperature from 37.4c to 38.7c and chills with no other remarkable changes in vital signs being noted.Transfusion of this platelet unit was stopped and later restarted following the temperature of 39.5c being noted at 5pm.The patient's pre-transfusion hospital course included spiking fevers and shortness of breath including a spike to 39c on the day prior to transfusion.These fever spikes were successfully treated with acetaminophen.There was no direct gram stain of the platelet bag contents.Pre and post transfusion patient blood cultures were no growth, and the patient was noted to be on antibiotics both pre and post transfusion.Culture of the platelet unit found both gram positive and gram negative rods with gram stain of the culture and bacillus circulans was identified on culture (one characteristic of b.Circulans is staining both gram positive and gram negative) routine transfusion reaction workup shows the clerical check of transfusion (right unit, right recipient?) to be correct; appearance of returned blood bag and contents to be normal and appearance of returned solutions, tubing, and filters to be normal.Special transfusion reaction workup was not done.The patient had peripheral blood cultures performed in conjunction with the unit, all were negative.Of note, the patient was receiving antibiotic meropenem (and micafungin) at the time.Another hospital reported no recipient adverse reaction to transfusion of the other platelet co-component at a (b)(4) hospital.E8341v00 paspllrpr1 was shipped to (b)(4) hospital of (b)(6) on (b)(6)2022 and transfused prior to notification.E8342v00 paspllrpr2 (involved product for this reported septic transfusion reaction) was shipped on (b)(6) 2022.E7644v00 apf24rt was located in-house and quarantined.E8341v00 was transfused without incident.The arc investigation included review of the donor records as well as a donor interview for bacterial contamination/septic reaction risks.Review of the donor results found a long time repeat donor with no previous hospital reports of being involved in any recipient adverse reaction.A comprehensive interview of the donor for possible bacterial contamination risks found a donor with no bacterial contamination risks, including no wounds or known infections.Per medical office follow-up, dr.Nobiletti indicated that there is no definitive information to rule in or rule out bacterial contamination resulting in a septic transfusion reaction.For example finding b.Circulans in the patient's post transfusion blood culture or the finding of gram positive/gram negative rods on direct gram stain of platelet bag contents would have been good evidence for contamination of the platelet unit.Since the platelet unit was a pathogen reduced unit, there is the possibility that any contamination, if the unit was contaminated, occurred only to the unit transfused at medstar georgetown university at some point following the pathogen reduced process, including the possibility of post transfusion contamination (note the slow growth of the organism on culture of the platelet bag contents).Based on the available information, arc cannot rule in or rule out bacterial contamination with bacillus circulans resulting in a septic reaction.
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Event Description
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Initial mdr information: on 9/18/2022, fresenius kabi was notified of a possible recipient reaction: recipient information: medstar georgetown university hospital reported a recipient reaction after receiving a platelet transfusion.The product was collected on (b)(6) 2022 and the transfusion occurred on (b)(6) 2022.Recipient was a 21-year-old male with a primary diagnosis of acute myeloid leukemia.The recipient was transfused with a pathogen-reduced apheresis platelets unit at (b)(6) hospital.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 there was no recipient reaction.Background: complaint information ( (b)(4)) arc#: (b)(4).Location: (b)(6) hospital.Platelet collection date: (b)(6) 2022.Platelet transfusion date: (b)(6) 2022.Pas treated: yes.Intercept treated: yes.Bacteria detected: bacillus circulans: found in the platelet bag.Co-product(s): the second platelet unit from the collection was transfused at children's hospital of philadelphia and there was no reaction.The plasma product was quarantined.Amicus product information: product description: amicus double needle advanced kit with platelet additive solution connector amicus code: 4r2352.Amicus lot: fa22e30158.Final manufacturing: haina, dr.Acda solution lot: fm22e31032.Naci solution lot: fm22f01033.Solution manufacturing: maricao, pr.Intersol (pas) product information: product description: intersol solution platelet additive solution 3 lntersol code: 6b7880.Intersol lot: fm22f11016.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: ce22b04l71.Registered manufacturer: cerus corporation, 1220 concord, ave, concord ca, 94520, usa.Investigation: code 4r2352, lot fa22e30158 used the following solution lots: acda solution lot: fm22e31032.Nacl solution lot: fm22f01033.A batch traceability (finished good (fg) lot) was performed to trace other amicus codes that used these solutions:· reported complaints on the above fg lots as of 10/12/2022 are as follows: the entire lot (fa22e30158) of (b)(4) kits were distributed to the american red cross as of 8/3/2022.Both haina and maricao flora recoveries were reviewed: haina: bacillus circulans was not recovered in the microbiology monitoring performed from january 2019 through may 2022.The fg lot was manufactured in may 2022.Bacillus circulans was recovered one (1) time in june 2022.The recovery was the month after the fg lot was manufactured.The recovery was not found in any area that amicus is manufactured in.Maricao uses mixing room 2 and filling line 4 for all amicus solutions, including intersol.Bacillus circulans was recovered one (1) time in january 2022.The recovery was not in may or june 2022 when the solutions lots were manufactured.The recovery was not found in mixing room 2 or filling line 4.The original platelet collection kit code 4r2352, lot fa22e30158 was not returned for evaluation.Fresenius kabi summary: based on complaint records, there are no additional adverse events reported against amicus lot fa22e30158 or any fg lot that used the same lots of solutions (nacl, acda, and intersol).A review of haina flora showed that bacillus circulans was recovered, however the recovery was identified outside of the manufacturing date of the fg lot involved in this incident.A review of maricao flora showed that bacillus circulans was recovered, however the recovery was identified outside of the manufacturing date of the solution lots involved in this incident and not in the clean room where the amicus and intersol solutions are manufactured.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.No conclusion has been determined at this time.The investigation continues and any additional information will be provided in a update to the mdr.Additional information received by fresenius kabi from the american red cross: patient was a 21-year-old male being treated for acute myeloid leukemia had a transfusion reaction to platelet unit (b)(6).The transfusion was started at 12:55 on (b)(6) 2022 and was marked by an increase in body temperature from 37.4c to 38.7c and chills with no other remarkable changes in vital signs being noted.Transfusion of this platelet unit was stopped and later restarted following the temperature of 39.5c being noted at 5pm.The patient's pre-transfusion hospital course included spiking fevers and shortness of breath including a spike to 39c on the day prior to transfusion.These fever spikes were successfully treated with acetaminophen.There was no direct gram stain of the platelet bag contents.Pre and post transfusion patient blood cultures were no growth, and the patient was noted to be on antibiotics both pre and post transfusion.Culture of the platelet unit found both gram positive and gram negative rods with gram stain of the culture and bacillus circulans was identified on culture (one characteristic of b.Circulans is staining both gram positive and gram negative) routine transfusion reaction workup shows the clerical check of transfusion (right unit, right recipient?) to be correct; appearance of returned blood bag and contents to be normal and appearance of returned solutions, tubing, and filters to be normal.Special transfusion reaction workup was not done.The patient had peripheral blood cultures performed in conjunction with the unit, all were negative.Of note, the patient was receiving antibiotic meropenem (and micafungin) at the time.Another hospital reported no recipient adverse reaction to transfusion of the other platelet co-component at a children's hospital.E8341v00 paspllrpr1 was shipped to (b)(6) hospital of philadelphia on (b)(6) 2022 and transfused prior to notification.E8342v00 paspllrpr2 (involved product for this reported septic transfusion reaction) was shipped on 08142022.E7644v00 apf24rt was located in-house and quarantined.E8341v00 was transfused without incident.The arc investigation included review of the donor records as well as a donor interview for bacterial contamination/septic reaction risks.Review of the donor results found a long time repeat donor with no previous hospital reports of being involved in any recipient adverse reaction.A comprehensive interview of the donor for possible bacterial contamination risks found a donor with no bacterial contamination risks, including no wounds or known infections.Per medical office follow-up, dr.Nobiletti indicated that there is no definitive information to rule in or rule out bacterial contamination resulting in a septic transfusion reaction.For example finding b.Circulans in the patient's post transfusion blood culture or the finding of gram positive/gram negative rods on direct gram stain of platelet bag contents would have been good evidence for contamination of the platelet unit.Since the platelet unit was a pathogen reduced unit, there is the possibility that any contamination, if the unit was contaminated, occurred only to the unit transfused at medstar georgetown university at some point following the pathogen reduced process, including the possibility of post transfusion contamination (note the slow growth of the organism on culture of the platelet bag contents).Based on the available information, arc cannot rule in or rule out bacterial contamination with bacillus circulans resulting in a septic reaction.Follow-up mdr information: maricao uses mixing room 2 and filling line 4 for all amicus solutions, including lntersol.Bacillus circulans was recovered one (1) time in december 2021 in the solution bioburden test for one lot manufactured on filling line 4.The recovery was not in may or june 2022 when the solutions lots were manufactured.The microorganism was submitted to a boil test, as required for all bacillus positive organisms, and it did not survive the test.This would indicate that the organism would not survive moist heat sterilization.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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