| Model Number INT2230B |
| 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 10/24/2023 |
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Event Type
Injury
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Event Description
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Transfusion transmitted bacterial infection.Initial information received: 02-nov-2023, 06-nov-2023, 12-nov-2023, 16-nov-2023, 17-nov-2023, 20-nov-2023, 21-nov-2023, 22-nov-2023.Executive summary: the patient involved in this report is a 73-year-old male · product complaint #: (b)(4).· manufacturing blood center: (b)(6) blood donation center.· intercept product code #: (b)(4).· collection instrument: amicus.· suspension medium: intersol platelet additive solution.· apheresis kit lot #: (b)(6).· pas intersol lot #: (b)(6).· product type: platelets: · implicated component product code #: (b)(4).· illuminator serial #: (b)(6).· implicated unit donation id # (din#): (b)(6).· intercept blood system for platelets processing set lot#: (b)(4).Case report [ (b)(4).]: on (b)(6) 2023, cerus received a spontaneous report of transfusion transmitted bacterial infection (ttbi) with an intercept treated platelet concentrate (pc) [transmission of an infectious agent via product] from the cerus chief medical officer (cmo).He was in communication with the medical director of transfusion services at duke university medical center and relayed the information to cerus global product safety.The event of ttbi was associated with (b)(6) units of intercept platelets concentrate (pc) ( (b)(4).; implicated unit blood component processing set lot #: (b)(4) ; product code: (b)(4).Manufactured from an apheresis collection of (b)(4).Platelets and (b)(4).Plasma.Each of the intercept pc were transfused to two different patients, one to the 73 y/o male patient at (b)(6) hospital who developed ttbi and the other to a patient at (b)(6) hospital without any issue.Additional information on the initial report was received on 06-nov-2023, 12-nov-2023, 16-nov-2023, 20-nov-2023 and 21-nov-2023 from divisional chief medical officer (cmo) at american red cross (arc).Donor information: the donor of the implicated unit (din#: (b)(6) ) was a 56-year-old male without a history of positive bacterial detection with platelet donation.He donated (b)(6) apheresis platelet and (b)(6) apheresis plasma components on 2023.Donor sample was taken pre-donation on (b)(6) 2023 08:09h for routine testing.No further information about the donor was reported.Implicated unit collection and manufacturing information: on 2023 from 08:09h to 09:56h, an apheresis collection of double apheresis platelets and double plasma was performed on the amicus (kit lot #: (b)().) at (b)(6) blood donation center, (b)(6).The apheresis platelets were suspended in intersol platelet additive solution (pas intersol lot#: (b)(6) ).On 2023, the implicated unit was treated with an intercept blood system large volume (lv) processing set and illuminated with the intercept illuminator serial number (b)(6) from 02:52h - 02:57h.There were no device malfunctions or irregularities associated with the intercept treatment process reported.Blood component(s) information: co-components of the implicated intercept pc the co-component platelet (din# (b)(6) , product code#: (b)(6) ) was transfused to an unknown patient without any adverse reaction and the platelet bag was discarded.The co-component plasma (din# (b)(6), product code #: (b)(6)) were not pathogen reduced and were quarantined by the arc.Patient clinical course: this report involved a 73-year-old male patient with a history of multiple myeloma and pancytopenia, who experienced a serious adverse event of ttbi following the transfusion of an intercept pc.The patient had received intercept treated blood products in the past without any transfusion reactions.On (b)(6) 2023 12:10h, same day as the ttbi adverse event, the patient received one unit of intercept pc in its entirely (din: (b)(6); 334ml) without any issue.On (b)(6) 2023, the implicated intercept pc (din# (b)(6) , component product code #: (b)(4) ) transfusion was started via a picc line that was place on (b)(6) 2023.Patient's pre-transfusion vital signs taken at 13:12h were body temperature of 36.2°c, blood pressure of 129/48 mmhg.At 13:39h, patient developed chills/rigors, fever (38.5°c) which eventually progressed to hypotension at 18:31h (bp: 84/49 mmhg).It was unclear exactly what time the transfusion was discontinued.Patient was hospitalized and treated with diphenhydramine 25 mg, famotidine 20 mg, montelukast 10 mg, morphine 3 mg, vancomycin and normal saline infusion.On (b)(6) 2023, gram stain and/or culture samples were obtained from the following sources: picc line, patient's peripheral blood and residual platelet bag.Picc line showed no growth while the patient's peripheral blood and residual platelet bag samples both grew out bacillus cereus (b.Cereus).Only the residual platelet bag sample was gram stained and it was positive for gram positive rods.After the occurrence of the transfusion reaction, there was a verbal report of "yolky appearance" of the implicated intercept pc by a floor provider.At unknown time, the outcome of the adverse event of ttbi with an intercept pc was reported as recovered/resolved.Investigations: cerus investigation: on (b)(6) 2023, cerus sent the transfusion reaction form to the representative at (b)(6).Medical center to provide additional information.This form was forwarded to the divisional cmo at arc to complete on (b)(6).Medical center's behalf.On (b)(6) 2023, cerus completed a batch record review for (intercept product code #: (b)(4) , processing set lot#: (b)(4) , manufacture date: 26-may-2023, expiration date: 08-jan-2024).The review of the batch records for the finished goods did not indicate any out-of-limits results during testing and controls.The product (processing set) met all quality requirements and specifications at the time of release.This batch was released on 31-aug-2023.There were no other complaints for lot (b)(4).The total batch size was 11,616 processing sets.On (b)(6) 2023, cerus received the completed transfusion reaction form from the divisional cmo at arc.On (b)(6) 2023, cerus received the implicated residual platelet bag and culture isolate along with co-component plasma units from arc for further investigation.Arc investigation: on (b)(6) 2023, the divisional cmo at arc confirmed the residual platelet bag was immediately inspected upon return to the blood bank on (b)(6).Neither blood bank staff nor the medical director thought the residual bag appeared yolky.The bag passed inspection on intake into hospital inventory, at time of issue to floor, as well as upon return to the blood bank.On (b)(6) 2023, the senior director of transfusion innovation and product development at arc reported a negative leak test and culture of the residual platelet.On (b)(6) 2023, cerus was informed by the divisional cmo at arc that the residual platelet bag (some residual platelets remaining; room temperature) and culture isolate from (b)(6) (frozen) along with co-component plasma units (frozen) will be shipped to cerus for further investigation.Adverse event assessment: 1.Transfusion transmitted bacterial infection (ttbi) [pt: transmission of an infectious agent via product].The reporter assessed the event as moderate in severity and serious due to hospitalization.Causality in relation to the intercept blood system for platelets device and to the transfused intercept pc was not reported.The cerus medical reviewer assessed the event of ttbi associated with b.Cereus as serious due to hospitalization.Causality was assessed as possible to the transfused intercept pc at the time of this preliminary assessment since additional investigations are still ongoing.B.Cereus is a common spore-forming environmental contaminant that is resistant to full pathogen reduction treatment.Given that the implicated intercept pc was a day 4 product, it is possible that a small residual amount of b.Cereus, especially in spore form, may have proliferated after successful intercept pathogen reduction treatment.At this time, it is unclear if the b.Cereus in the implicated intercept pc was present pre or post-intercept treatment.Further analysis of the processing bag integrity and culture isolate gene sequencing must be completed to fully evaluate this adverse event.Although the patient's picc line and peripheral blood culture results are discordant, his clinical response during the transfusion was consistent with an acute septic reaction manifesting in fever and hypotension.The causality was assessed as possible in relation to the intercept blood system for platelets device at the time of this preliminary assessment since additional investigations are still ongoing.B.Cereus is a common environmental spore-forming organism that may be found on the skin.B.Cereus is effectively inactivated in the vegetative state but the spore form is known to be relatively resistant to the intercept process and this is stated in the manufacturers' instruction for use.Transmission of b.Cereus contaminated platelets is a rare but known complication, even when the intercept process is performed appropriately.The cerus medical reviewer considered the listedness for the event to be listed for transfused intercept pc and intercept blood system for platelets device based on applicable cerus safety reference information.
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Event Description
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Cerus received additional follow up information on this event on 02-dec-2023, 07-jan-2024, 08-jan-2024, 09-jan-2024, 11jan2024, 12-jan-2024, 23-jan-2024 25-jan-2024, and 6-feb-2024 added implicated intercept pc information.Blood component(s) information: (new information) implicated intercept pc there were no reports of deviation or visual abnormalities of the implicated intercept pc unit (din#: (b)(4), product code#: e8342v00).Patient clinical course.(revised information) on (b)(6) 2023 12:10h, same day as the ttbi adverse event, the patient received the first of two units of intercept pc in its entirety (din: (b)(4); 334ml) without any issue.Around 13:12h, the implicated intercept pc (din# (b)(4), component product code #: e8342v00) transfusion was started via a picc line that was place on (b)(6) 2023.Updates to investigations: investigations cerus investigations (new information).On (b)(6) 2023, cerus shipped the implicated residual platelet bag to fenwal, la chatre for additional testing.On (b)(6) 2024, sequencing results of bacteria recovered from the implicated residual platelet bag, its culture isolate and two plasma co-components, using standard bacterial culturing and isolation methods with both broth and agar media, were received from charles river laboratories.16s rrna sequencing confirmed identification of all bacterial isolates as belonging to the b.Cereus group.Results from proseq analysis using the target gene pyca identified these isolates as b.Thuringiensis with confidence at the species level.Additional sequence analysis by multilocus sequence typing (mlst) confirmed the identity of these strains as b.Thuringiensis and that these isolates were indistinguishable from each other based on the sequencing of the glpf, pur, and pyca genes.On the same day, cerus sent the plasma co-components to the arc holland lab for repeat testing because of the discrepant culture results between cerus and arc holland lab.On (b)(6) 2024, cerus microbiology and lab services reported negative results of repeat culture testing for both co-component plasma units in broth and agar media.Arc investigations (new information).On (b)(6) 2023, no aggregates or macroscopic leaks in the implicated residual platelet bag were observe.Bact/alert bottle culture taken from the implicated residual platelet bag became positive between 5-6 hours.Plate culture showed beta hemolytic colonies, gram positive rods with spores - bacillus species.Both co-component apheresis plasma units had negative culture results after incubation for 7 days on the bact/alert.On (b)(6) 2024, colonies from the implicated residual platelet bag and its culture isolate were identified as bacillus cereus group using the bacillus analytical profile index (api) test strips from biomerieux.The bacillus cereus group shows high genomic similarity and includes b.Thuringiensis, b.Cereus, b.Anthracis, b.Mycoides, b.Pseudomycoides, and b.Weihenstephanensis.On (b)(6) 2024, cerus received the results for repeated testing of the co-component plasma units from arc holland laboratory and both were negative using various culture media methods.Given the inability to reproduce the initial positive culture result by cerus and the negative culture results from repeat testing at the arc holland laboratory, the overall interpretation of the co-component plasma culture testing was indeterminant.Fenwal intercept processing set manufacturer investigation: (new information) on 12-jan-2024, cerus received the final investigation report from fenwal: visual inspection of the implicated residual platelet bag showed that both outlet ports (twist off protector) have been used.One of the ports was used by the duke nursing staff for the transfusion (the port which is spiked with an attached infusion set) and the 2nd port was accessed to culture the implicated residual platelet bag.The implicated residual platelet bag showed no visual or sealing defect.An underwater pressure test at 0.6 bar did not identify any leaks.A bend test was also performed on all connections in the storage container, and no total or partial disconnection were found.The physical integrity of the implicated residual platelet bag was not compromised.Without examination of the entire processing kit (cad and illumination containers), it is not possible to definitively conclude the cause of the bacterial contamination reported.The review of the batch records indicated that there was no visual and functional defect detected.History did not reveal any manufacturing trend.In the absence of a confirmed cause related to the manufacturing process, no corrective action was identified for implementation.Revised and new information adverse event assessment (revised information) the reporter assessed the event as moderate in severity and serious due to hospitalization.Causality in relation to the transfused intercept pc and the intercept blood system for platelets device were not reported.(new information) the cerus medical reviewer assessed the event of ttbi associated with b.Cereus as serious due to hospitalization.Although cerus's investigation identified b.Thuringiensis while the arc holland laboratory identified b.Cereus in the implicated intercept pc.The fact is b.Cereus and b.Thuringiensis are very similar organisms that can generally only be differentiated by sequencing.(revised and new information) causality was assessed as certain to the transfused intercept pc.Bacillus species is a common spore-forming environmental contaminant that is resistant to full pathogen reduction treatment.Given that the implicated intercept pc was a day 4 product, it is possible that a small residual amount of bacillus species, especially in spore form, may have proliferated after successful intercept pathogen reduction treatment.Fenwal's investigation ruled out loss of implicated residual platelet bag integrity or a manufacturing defect, thus it is most likely that the origin of bacillus species contamination was from the apheresis donation.Although the patient's reported picc line and peripheral blood culture results from the hospital were discordant, his clinical response during the transfusion was consistent with an acute septic reaction manifesting in fever and hypotension.Cerus microbiology lab independently confirmed the presence of bacillus species in the implicated residual platelet bag and its culture isolate, corroborating the results obtained by both duke raleigh hospital and the arc holland laboratory.Co-component plasma components yielded non-reproducible culture results between the cerus microbiology laboratory and the arc holland laboratory.The causality was assessed as probable in relation to the intercept blood system for platelets device.Bacillus species is a common environmental spore-forming organism that may be found on the skin.While intercept pathogen reduction technology can effectively inactivate this bacterium in the vegetative state, the spore form is known to be relatively resistant.This known resistance is noted in the manufacturers' instruction for use.Transmission of bacillus species contaminated platelets is a rare but known complication, even when the intercept pathogen reduction process is performed appropriately.
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