| Model Number INT2130B |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Insufficient Information (4580)
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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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Transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] date cerus received: (b)(6) 2021, (b)(6)2021, (in).The patient involved in this report is a (b)(6), female.Product complaint #: (b)(4).Product code #: int2130b (arc blood product code #e8341v00).Set lot #: ce20h20l71 (fenway amicus apheresis kit lot fa21e03172, pas lot fm21d28032).Illuminator serial #: (b)(4).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 (b)(6).The event was reported by (b)(6).The notification occurred during a follow-up call for a separate case from (b)(6) clinic (case ref #(b)(4)).The initial report was a notification to cerus of a possible transfusion reaction in a patient involving an intercept treated platelet concentrate (pc) transfusion at the university (b)(6) health system (b)(6) center in (b)(6), (b)(6) cancer center (ambulatory clinic for cancer patients associated with the (b)(6) health system, about 40 min drive from (b)(6)).Further information on the initial report was received from (b)(6), a capa quality engineer at (b)(6).On (b)(6) 2021, (b)(6) 2021.Platelet collection: on (b)(6) 2021 13:20h, a double apheresis (leukocyte-reduced) platelet component was collected on fenwal amicus apheresis machine at the (b)(6) blood donation center - mid-atlantic region.The apheresis platelets were stored in pas solution.The double-apheresis component was split and treated with two intercept processing sets for small volume platelets.The donor was a (b)(6) b positive female with a history of nine donations in eprogesa system.The donor had four deferrals between (b)(6) 999 and (b)(6) 2020 for various reasons including: "a reactive test result, physical finding, and health history".Samples were taken at the time of collection, and all standard cts/infection testing was completed.No further information on the donor was available and the donor was considered lost to follow-up after several failed attempts to contact her.On (b)(6) 2021, the implicated pc unit (din: (b)(4), product code: int2130b, expiration date: 03-jul-2021, arc product code: e8341v00) was treated with an intercept blood system small volume storage (sv) processing set at the (b)(6) manufacturing center.From 12:30h - 12:37h, the implicated unit was illuminated as part of treatment with the intercept blood system for platelets.The treatment report showed successful illumination with no indication of illuminator malfunction or irregularities.The 3 product codes listed below were the products from the unit for the involved din.1.Co-component intercept-treated unit (treatment performed with a separate sv set) e8342v00 was shipped to (b)(6) on (b)(6) 2021 and transfused without any incident on (b)(6) 2021 to another patient (note that this unit was not part of the shipment to (b)(6) with the implicated unit, as detailed below).2.Unit e7644v00 was discarded (reason unknown).3.Unit e8341v00 - implicated unit, was shipped to (b)(6) and transfused on (b)(6) 2021.The details of remaining 2 pathogen reduced products are not available.On 01-jul-2021, the implicated unit was shipped with the following pathogen-reduced products to (b)(6) in the same transporter: (reporter can obtain information about the other units that were shipped from eprogesa if necessary).(b)(4) (e8341v00), a-, expired on 03-jul-2021 (b)(4) (e8342v00), a+, expired on 03-jul-2021 (b)(4) (e8341v00), b+, expired on 03-jul-2021= implicated unit- transfused (b)(4) (e8341v00), a+, expired on 03-jul-2021 (b)(4) (e8342v00), a+, expired on 03-jul-2021 patient's clinical course: this report involves a (b)(6), female patient, who experienced a serious event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] following a transfusion of intercept pc.The patient was located in (b)(6) health system (b)(6) center, a (b)(6) satellite outpatient cancer care facility) during the time of the event.The patient's past medical and surgical history included endocarditis s/p mitral valve surgery (2016) and a gliosarcoma in (b)(6) 2021.The patient underwent a craniotomy because of subsequent gliosarcoma progression.It was noted the current treatment course for gliosarcoma was complicated by persistent thrombocytopenia which required multiple transfusions.The patient had no documented history of transfusion reaction prior to the reported event.Concurrent conditions included, chronic obstructive pulmonary disease (copd), myasthenia gravis, heart failure, hypothyroidism, type 1 diabetes mellitus (iddm), and atrial fibrillation s/p pacemaker placement.The patient's concomitant medication included avastin [simvastatin]- treatment for gliosarcoma, lomustin [lomustine] - treatment for gliosarcoma, mestinon [pyridostigmine bromide] for myasthenia gravis, and dexamethasone [dexamethasone] for gliosarcoma.Prior to transfusion, the patient was clinically stable.On (b)(6) 2021 12:25h, the patient began the transfusion of the implicated unit of an intercept pc (din: (b)(4), product code: int2130b) for thrombocytopenia.During the transfusion, she experienced a life-threatening transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] which involved a transfusion reaction of septic shock.At 3:00h, she developed an acute onset of fever (to 40.8°c).Additionally, she experienced nausea/vomiting, hypotension, chills/rigors, hypoxemia, dyspnea, and wheezing.The transfusion was discontinued due to the transfusion reaction, and she was sent to the emergency department (ed) at (b)(6) hospital ((b)(6); facility not associated with (b)(6) health system).The patient was admitted to the intensive care unit (icu) with a diagnosis of septic shock post transfusion.While admitted, she was in an acute respiratory failure with hypoxia, which required oxygen supplementation.She was treated with vancomycin and meropenem for septic shock.Also, a low dose of peripheral vasopressors was started.She was also started on stress dose steroids with hydrocortisone, as she was functionally adrenally suppressed due to treatment with chronic dexamethasone for her recurrent gliosarcoma.Subsequently, she was hypotensive with a mean arterial pressure (map) of 65 (units and reference ranges not reported, presumed mmhg).The patient's lactic acid was 5.8 (units and reference ranges not reported, presumably mg/dl) and platelet count was at 27,000.The patient was found to be neutropenic with a white blood cell count (wbc) of 0.5 (units and reference ranges not reported).Blood cultures (obtained in the ed) grew out a gram-negative organism identified by vitek at (b)(6) as leclercia adecarboxylata, although, after further discussions between the lab at (b)(6) and dr.(b)(6) (director of microbiology) at (b)(6), the (b)(6) lab changed the identification to enterobacter sp.No gram positives grew out of the patient blood cultures.By (b)(6) 2021, the patient was feeling much better.On the same day, blood cultures had showed no growth.At some point the patient was moved out of the intensive care unit (icu) into a regular acute care floor (timing unavailable).An infectious disease (id) consult obtained on (b)(6) 2021 stated that the patient was doing very well and recommended that the patient be kept inpatient while finishing unspecified intravenous (iv) antibiotics.Given patient's existing comorbidities (myasthenia; thrombocytopenia), id recommended against oral 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 thereafter.On an unreported date and time, the event of transfusion-transmitted bacterial infection [pt: transmission of an infectious agent via product] was reported as recovered/resolved.Product investigations: cerus investigation: the residual bag was discarded, so it was not available for integrity testing or further residual product testing.A batch record review for int2130b lot ce20h20l71 was performed.The released product met all functional and quality requirements.A review of the batch history indicated that there was one other complaint for this batch for a leak detected upon receipt by a hospital consignee.There was no report of leak or device malfunction associated with the current case.(b)(6) investigation: the (b)(6) microbiology lab performed a detailed internal investigation which included the following: on (b)(6) 2021, the day of the transfusion reaction, the platelet bag was sent back to (b)(6) medical center, and culture samples and gram stain were obtained.The gram stain showed 3+ gram-negative rods and a few gram-positive cocci.The platelet bag cultures grew out two morphologically distinguishable gram-negative rods identified as leclercia adecarboxylata as well as an enterobacter species, and staphylococcus saprophyticus.(b)(6) performed a whole genome sequencing at (b)(6) wgs facility on the gram-negative rods (leclercia adecarboxylata and enterobacter sp.) from the platelet bag, as well as the enterobacter from the patient.The enterobacter from the patient bc and the enterobacter from the plt bag appeared to be highly related, perhaps identical.A sample from the platelet bag grew: coagulase negative staphylococcus (confirmed to be staphylococcus saprophyticus).·leclercia adecarboxylata (id by maldi-tof) · enterobacter species (sp.).(possibly e.Cancerogenous by 16s sequencing) (initially, mass spectrometry identified this bacterial isolate as leclercia; recategorized as enterobacter after 16s sequencing).Patient blood culture grew: enterobacter sp.(possibly e.Cancerogenous by 16s sequencing) (initially, mass spectrometry identified this bacterial isolate as leclercia; it was recategorized as enterobacter sp.After discussion between (b)(6) lab and dr.(b)(6)).(b)(6) performed whole genome sequencing (wgs) on: leclercia adecarboxylata (id by maldi-tof) from the platelet bag · enterobacter sp.(possibly e.Cancerogenous by 16s sequencing) from the platelet bag · enterobacter sp.(possibly e.Cancerogenous by 16s sequencing) from the patient's blood culture the isolate identified as leclercia adecarboxylata was not related to either of the enterobacter isolates.(b)(6) believed that the two enterobacter sp.(possibly e.Cancerogenous by 16s sequencing) from the platelet unit and the patient's blood culture are closely related.The routine transfusion reaction workup was also performed to include clerical check of transfusion, appearance of returned blood bag and contents and the appearance of returned solutions, tubing and filters were correct and normal.It was concluded that "certain septic transfusion reaction occurred and was due to enterobacter sp.".(b)(6) investigation: on 27-aug-2021, staphylococcus saprophyticus isolates were shipped and delivered to the center for disease control and prevention (cdc) for whole genome sequencing (wgs).The result is pending.Additional investigations, including medical office follow up, collection record review, manufacturing record review, equipment and supplies acceptability for use, equipment check by vendor, "sepd" logs, and external regulatory correspondence or visits, were all pending at the time of this report.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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Cerus received additional follow up information on this event on 16-sep-2021, 19-oct-2021, 02-nov-2021, 04-nov-2021; 20-jan-2022 , 07-feb-2023.New information: further information on the initial report was received from (b)(6), a capa quality engineer at the arc in washington, d.C., (b)(6) from uva clinical microbiology and molecular diagnostics, charles river laboratories (newark, delaware), and midi labs (newark, delaware) on 20-aug-2021, 27-aug-2021, 02-sep-2021, 09-sep-2021, 16-sep-2021, 19-oct-2021, 02-nov-2021, 04-nov-2021, 20-jan-2022, 07-feb-2023.Updates to platelet collection information (revised information).On 29-jun-2021, the implicated pc unit (din: w20292180140900v, product code: int2130b, expiration date: 03-jul-2021, arc product code: e8341v00) was treated with an intercept blood system small volume (sv) processing set in the arc mid-atlantic region.The implicated unit was illuminated with intercept illuminator serial number (b)(6) from 12:30h - 12:37h.Updates to patients clinical course (revised information).The patient was located in uva health system hope center (an ambulatory clinic for cancer patients in augusta, va) during the time of the event.The patient underwent a craniotomy for gliosarcoma excision.On 02-jul-2021 12:25h, blood cultures were taken.Subsequently, the patient was admitted to the intensive care unit (icu).While admitted, she was in an acute respiratory failure with hypoxia, which required oxygen supplementation.Her mean arterial pressure "less than" 65 mmhg and was acutely disoriented.The patient's lactic acid was 5.8 mmol/l and platelet count was at 27,000/ul.The patient was found to be neutropenic with a white blood cell count (wbc) of 0.5 k/ul.Deleted information: subsequently, she was hypotensive with a mean arterial pressure (map) of 65 (units and reference ranges not reported, presumed mmhg).Updates to cerus investigations (new information).A batch record review (product code: int2130b; lot #: ce20h20l71; date of manufacture: 20-aug-2020; expiration date: 31-jan-2022 was performed.On 16-sep-2021, cerus received from uva clinical microbiology and molecular diagnostics four bhi agar slants, three platelet isolates (staphylococcus saprophyticus (s.Saprophyticus), gram negative bacillus, and l.Adecarboxylata) from implicated pc (w20292180140900v), and one patient isolate (gram negative bacillus).On 21-sep-2021, cerus sent the samples to charles river and midi labs for sequencing.On 20-jan-2022, cerus received final sequencing data from charles river: per cerus bacteriology, "additional sequencing data was received from charles river confirming the identity of leclercia adecarboxylata.Analysis of multi-locus sequence typing (mlst) compared this strain to the strains identified from wake forest and cleveland clinic.The l.Adecarboxylata uva strain was observed to have a different sequence type than the strains from cleveland clinic strain and wake forest." cerus bacteriology was planning on performing pathogen inactivation (pi) studies.The result was pending at that time.On 07-feb-2023, cerus completed the bacterial investigation of the implicated unit, w20292180140900v (e8341v00), and the patient sample.Final cerus bacteriology summary as of 07-feb-2023 indicated that the bhi slants received by cerus from university of virginia health on 16-sep-2021 were identified as: 1.Bb, plt w202921801409: staphylococcus saprophyticus, as confirmed by charles river lab (newark, delaware) by multi-locus sequence typing (mlst) was compared to the s.Saprophyticus strain of the corresponding strain identified from wake forest cleveland clinic and was confirmed identical with that strain.2.Bb, plt w202921801409-1 uvamc_00000007_01: gram negative bacillus (identified as enterobacter soli by charles river labs but as enterobacter asburiae by midi labs (newark, delaware) using 16s rrna sequencing and fame (fatty acid methyl ester) analysis.3.Bb, plt w202921801409-1 uvamc_00000007_02: leclercia adecarboxylata (confirmed by charles river labs, and was not identical to wake forest cleveland clinic strain).4.Patient isolate uvamc_00000008_01: the bacterial identification for the patient sample was enterobacter soli.The sequencing results were indistinguishable from the enterobacter soli in the platelet sample (as identified by charles river labs).Pathogen inactivation studies were performed on these bacteria both individually and in combination in platelets in pas using the intercept platelet processing set and the uva illuminator.S.Saprophyticus, l.Adecarboxylata, and e.Soli were inactivated (individually and in combination) by 7 log cfu/ml with no bacterial growth detected up to day 7 after storage.Updates to arc investigation (new information): additional investigations, including medical office follow up, collection record review, manufacturing record review, equipment and supplies acceptability for use, equipment check by vendor, "sepd" logs (nc-0301743), and external regulatory correspondence or visits, were all found to be acceptable by arc at the time of this report.The arc believes that this was a case of septic reaction following transfusion of a pathogen-reduced platelets.Since the residual platelet bag was not available for visual inspection, it was unknown if there was a micro-defect in the bag that resulted in bacterial contamination of the product.The bacterial source contributing to this event remained unknown.Updates to cerus medical reviewer assessment (revised and new information).The cerus medical reviewer assessed 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 malfunction as the treatment record did not show irregularities in the pathogen reduction process and showed that a successful illumination of the pc product was performed and the pathogen inactivation studies performed on the pathogens both individually and in combination in platelets in pas using the intercept platelet processing set and the uva illuminator showed that s.Saprophyticus, l.Adecarboxylata, and e.Soli were completely inactivated (individually and in combination) by 7 log cfu/ml with no bacterial growth detected up to day 7 after storage.Since cerus microbiology laboratory was able to completely inactivate this bacteria at a very high input titer, it supports the likelihood of a post-intercept treatment environmental contamination perhaps 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 with the breach of the platelet transfusion bag integrity.However, as the bag in this case was discarded without inspection, his hypothesis cannot be confirmed or ruled out.The cerus medical reviewer considers this event to be expected due to the belief that contamination occurred after a successful pathogen reduction treatment with intercept blood system for platelets device.
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