| 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 12/31/2021 |
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Event Type
Death
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Event Description
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Transfusion transmitted infection.Date cerus received: 20-jan-2022, 23-jan-2022, 26-jan-2022, 28-jan-2022(in).The patient involved in this report was a (b)(6) male.Product complaint #: (b)(4).Intercept product code ((b)(6)): int2230b.Intercept product code ((b)(6)): not reported.Confirmed implicated arc blood product code and din #: e8341/ (b)(6) (co-component 1, transfusion #5).Other non-implicated (b)(6) blood product codes and din#(s): e8342/ (b)(6) (co-component #2, transfusion#1), e8342 /(b)(6) (co-component 2, transfusion #2).Presumed (b)(6) blood product code/ din#: e8332/ (b)(6) (co-component 1, transfusion #3).Implicated (b)(6) set lot #: ce21g05l71 (fk kit lot # fa21j11226 / pas intersol lot #fm21g15032) (co-component 1, transfusion#5).Other non-implicated (b)(6) set lot#(s): ce21g05l71 [(fk kit lot# fa21j11226/pas intersol lot# fm21124030, co-component 1 transfusion #1), (fk kit lot # fa21i16184/ pas intersol lot # fm21h25047, co-component 2, transfusion #2)].Presumed (b)(6) set lot#: not reported (co-component 1, transfusion #3).Illuminator serial #: not reported.On 20-jan-2022, cerus 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 (b)(6).(b)(6) received a report from the (b)(6) and was asked to investigate a patient's death that occurred at the (b)(6) over the (b)(6) 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)(6), set lot #ce21g05l71, product code: int2230b) transfused at (b)(6) that was prepared at the (b)(6).Further information on the initial report was received from (b)(6), at the (b)(6) on 23-jan-2022, 26-jan-2022, and 28-jan-2022.(b)(6) collection information: on (b)(6) 2021, a donation of red blood cells (rbc) (red cells as-1 500ml-leured) was collected for the irradiated rbc transfused to the patient on (b)(6) 2021 at 20:38h (transfusion #4; e0332, (b)(6)).It was reported this unit was manufactured and distributed from the (b)(4).Details on the donor for this specific unit were not reported.On (b)(6) 2021, a donation of apheresis platelet was collected for the intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated) transfused to the patient on (b)(6) 2021 at 11:10h (transfusion #1; e8342, (b)(6), set lot #ce21g05l71).It was reported this unit was manufactured and distributed from the (b)(4).Additionally, this intercept pc unit was noted as co-component #2.Details on the donor for this specific unit were not reported.On the same day, a donation of apheresis platelet was collected for the intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated) transfused to the patient on (b)(6) 2021 at 20:34h (transfusion #2; e8342, (b)(6), set lot #ce21g05l71).It was reported this unit was manufactured from the (b)(4) and distributed by (b)(4).Additionally, this intercept pc unit was noted as co-component #2.Details on the donor for this specific unit were not reported.On (b)(6) 2021, a donation of apheresis platelet was collected for the implicated intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated) transfused to the patient on (b)(6) 2021 at 09:07h (e8341, din #(b)(6), set lot #ce21g05l71, product code: int2230b).The implicated intercept pc was from the (b)(4).It was noted that this collection was also manufactured and distributed by (b)(4).The implicated intercept pc was noted as co-component #1 (transfusion #5).The sample was collected from an a positive donor.At the time of this report, it was reported 3 out of 4 donors had been assessed for risks.All donors had been temporarily deferred per arc procedures.No further details about the donors were reported.(b)(6) collection information: on an unreported date, intercept pc was also collected from (b)(6) was collected for the intercept pc transfused to the patient on (b)(6) 2021 at 23:36h (e8332, din #(b)(6)).Details regarding this collection and donor information were not reported.Patient's clinical course.This report involves a (b)(6) patient, who experienced a serious (fatal) transfusion reaction of a suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] following the transfusion of an intercept pc.A summary of the patient's transfusions leading up to the event included the following: transfusion #~transfusion date/start time~product description | din | isbt code 1:(b)(6) 2021 11:10h ~~apheresis, pathogen-reduced pas platelet (co-component #2; from (b)(4)) | (b)(6) | e8342, set lot #ce21g05l71.2:(b)(6) 2021 20:34h~~apheresis, pathogen-reduced pas platelet (co-component #2; from (b)(4) and distributed to (b)(4)) | (b)(6) |e8342, set lot #ce21g05l71.3:(b)(6) 2021 23:36h~~apheresis, pathogen-reduced platelet (co-component #1; presumed from (b)(6)) | (b)(6) | reported as e8332.4:(b)(6) 2021 20:38h ~~irradiated rbc | (b)(6) (from (b)(4)) | e0332.5 :(b)(6) 2021 09:07h~~apheresis, pathogen-reduced pas platelet (co-component #1implicated unit from (b)(4)) | (b)(6) | e8341, set lot #ce21g05l71, product code: int2230b.The patient's medical history included mucor sinusitis [pt: mucormycosis] ((b)(6) 2021), "cn" (cranial nerve) palsies [pt: vith nerve paralysis] (unk; status post multiple debridement's and prolonged course of ambisome), and "le" (left extremity) deep vein thrombosis (dvt) [pt: deep vein thrombosis] (unk; status post "l" (left) iliac vein stent and mechanical thrombectomy, "r" (right) iliac stent placement (b)(6) 2021).The patient's past procedures included inferior vena cava (ivc) filter ((b)(6) 2021).Concurrent conditions included stage iv germinal center diffuse large b-cell lymphoma (dlbcl) (status post chemotherapy, with progression and poor oncologic prognosis), pancytopenia, gastrointestinal (gi) bleeding, anemia, and decubitus ulcer.The patient's concomitant medication was not reported.The patient had a transfusion history which included multiple platelets and red blood cells, and a "rare" cryoprecipitate; however, a history of transfusion reaction prior to the reported event was not documented.On an unreported date, the patient had recently been restarted on chemotherapy and was pancytopenic.On an unreported date, the patient was admitted to an outside (osh - unspecified) hospital in (b)(6) with gi symptoms.He was found to have progressive lymphoma with extensive disease burden complicated by tumor lysis syndrome (tls) or disseminated intravascular coagulation (dic).Additionally, the patient had acute kidney injury (aki) which required continuous renal replacement therapy (crrt).The patient had hypoxic respiratory failure requiring intubation, presumed septic shock, altered mental status (ams), and bowel obstruction.On (b)(6) 2021, the patient was admitted to (b)(6) status post chemotherapy with progression.He was transferred for further management and with a poor oncologic prognosis.It was noted that the patient had a history of sepsis, fungal infection, and wound infection prior to transfer to ucsf.Subsequently, the patient had arrived with a decubitus ulcer.It was reported the patient's wound may have been colonized with acinetobacter spp.Bacteria at the time of admission.No cultures were taken from this wound.During his (b)(6) hospitalization, he had renal recovery and was extubated.However, the patient had ongoing sepsis physiology, encephalopathy, and generalized weakness.The patient was improving on unspecified steroids or other therapies.On (b)(6) 2021 at 11:10h, the patient received transfusion #1, intercept pc (din #(b)(6), co-component #2).It was reported transfusion #1 was manufactured and distributed by (b)(4).At 20:34h, the patient received transfusion #2, intercept pc (din # (b)(6), co-component #2).Transfusion #2 was noted as manufactured by (b)(4) and distributed to the (b)(4).At 23:36h, the patient received transfusion #3, intercept pc (din # (b)(6), reported as co-component #1).At the time of this report, it was presumed transfusion #3 was manufactured and treated at (b)(6).The indication for all 3 of these transfusions was not reported, and the patient had no transfusion reactions reported that were related to these transfusions.No further details regarding the patient's clinical status (including labs) were reported for this day.On (b)(6) 2021 at 20:38h, the patient was transfused with 250 ml of irradiated red blood cells (rbc) (din #(b)(6); manufactured and distributed by (b)(4)) for anemia.Additional details regarding the patient's clinical status (including labs) were not reported.On (b)(6) 2021 early morning, the patient experienced acute gi bleeding with hypotension and tachycardia.At 08:38h, the patient's vitals included: blood pressure: 114/58 (units not reported, presumably mmhg).Heart rate: 155 (units not reported, presumably bpm).Temperature: 37.2 (units not reported, presumably degrees celsius).The patient's pre-transfusion blood cultures were reported as negative.The timing of these cultures was not reported.At 09:07h, the patient was fully transfused with 250 ml implicated intercept pc (din #(b)(6), product code: int2230b) for his thrombocytopenia (platelet count of 15k) and gi bleeding.This was the intercept pc from the (b)(6) and was transfused approximately 36 hours from the patient's last intercept pc transfusion (transfusion #3, presumed from (b)(6)).The patient experienced a suspected transfusion transmitted infection [pt: transmission of an infectious agent via product] after the last transfusion.At 90 minutes after the end of the intercept pc transfusion, the patient's vitals included: blood pressure: 93/52 (units not reported, presumably mmhg).Heart rate: 143 (units not reported, presumably bpm).Temperature: 36.6 (units not reported, presumably degrees celsius).The patient's post-transfusion platelet count was 10k.At 13:01h, the patient had an unspecified reaction (no additional information reported), and the patient's blood was collected and cultured.It was reported that two central blood cultures were drawn (red port and purple port).It was noted a septic transfusion reaction could not be ruled out.At an unreported time, the patient's condition deteriorated further.He developed dyspnea, hypoxia, tachycardia, hypotension, and fever.Subsequently, he was transferred to the intensive care unit (icu) for further management and monitoring.Soon after transferring to the icu, the patient had worsening lactate and acidosis.He was treated with maximum dose norepinephrine, vasopressin, and epinephrine.On (b)(6) 2022 at approximately 00:48h, the preliminary culture results showed gram negative, isolated rods that were identified as acinetobacter baumanii complex (acbc).The blood bags from the last plt transfusion were not investigated or cultured, as no transfusion reaction was recognized at the time of transfusion.At 11:33h, the patient's sepsis symptoms worsened, and the patient died.The patient had orders of do not resuscitate (dnr) and do not intubate (dni).The patient's family agreed to no further escalation of care.It was not reported if an autopsy was completed, or if a death certificate was available (request pending).The cause of death was reported as sepsis.On (b)(6) 2022 at 16:16h, the final results confirmed the carbapenem (multidrug) resistant a.Baumanii complex (crab).On the evening of 13-jan-2022, (b)(6) sent the patient's post-transfusion stab agar sample to the cdc for whole genome sequencing (wgs).On the morning of 14-jan-2022, "dcsc" notification to the cdc with a tracking number for shipment was issued.Investigations: cerus: a batch record review (int2230b, set lot #ce21g05l71, date of manufacture 05-oct-2021, expiration date is 31-dec-2022) was performed.The released product met all functional and quality requirements.A review of the batch history indicated that there have been no other complaints reported for this finished goods lot.The full batch size was (b)(4) units, and was released by cerus quality assurance on 15-oct-2021.Cerus further investigated if the patient's acbc was the same strain that had been implicated in multiple platelet septic events, countrywide, including a case 3 years ago at ucsf.It was noted that there were currently 6 - 7 cases, including 2 fatalities over the extended time period.The acbc strain involved within these cases was sensitive to most antibiotics, which suggested it was not a hospital-derived strain.Cerus requested the antibiotic resistance pattern of the septic patient's acbc isolate be shared.Dr.(b)(6), md, ph.D., director at (b)(6) clinical microbiology laboratory confirmed that the septic patient's acbc isolates detected the ndm[-1] gene indicative of a multi-drug resistance.Laboratory cultures performed at ucsf confirmed resistance to the majority of antibiotics tested.The antibiotic susceptibility test (ast) performed included the following results: antibiotic: acbc minimum inhibitory concentration (mic) sensitivity ampicillin and sulbactam:16:r.Cefepime:16:r.Ceftazidime:16:r.Ciprofloxacin:2:r.Gentamicin:8:r.Levofloxacin:8:r.Meropenem:8:r.Piperacillin and tazobactam:64:r.Tobramycin:8:r.Trimethoprim and sulfamethoxazole:2:r.Therefore, it was evident that the septic patient's acbc isolate was phenotypically not the same as the "sensitive" acbc strains implicated in the prior events.(b)(6): on 04-jan-2022 at 18:03h, the hospital epidemiology and infection control (heic) team notified transfusion service of this event so investigation of a possible septic transfusion reaction could be initiated since the patient had been transfused with blood products in the days preceding the positive blood culture, and acinetobacter species have recently been identified as a pathogen of concern in apheresis platelet units (fda communication, 02-dec-2021).A summary of lookback was initiated by the transfusion service (only including blood products transfused between 00:01h on 29-dec-2021 and 13:01h on 31-dec-2021 when the positive blood culture was drawn): transfusion #~transfusion date/start time~product description | din | isbt code 1: (b)(6) 2021 11:10h: apheresis, pathogen-reduced pas platelet (co-component #2; from (b)(4)) | (b)(6) | e8342, set lot #ce21g05l71.2: (b)(6) 2021 20:34h~~apheresis, pathogen-reduced pas platelet (co-component #2; from (b)(4) and distributed to (b)(4) | (b)(6) |e8342, set lot #ce21g05l71.3: (b)(6) 2021 23:36h: apheresis, pathogen-reduced platelet (co-component #1; presumed from (b)(6) donation) |(b)(6) | reported as e8332.4: (b)(6) 2021 20:38h: irradiated rbc | (b)(6) (from (b)(4)) | e0332.5: (b)(6) 2021 09:07h: apheresis, pathogen-reduced pas platelet (co-component #1; implicated unit from (b)(6)) | (b)(6) | e8341, set lot #ce21g05l71, product code: int2230b.No transfusion reactions were reported to the transfusion service for any of the products listed including the intercept pc transfused on (b)(6) 2021.Hence, there were no additional investigations required or undertaken by the transfusion service after the products were issued to the patient.It was reported that ucsf notified the (b)(6), the federal drug administration (fda), the (b)(6), and (b)(6) of the fatal event.The patient's acbc isolate had an ndm[-1] gene that was found to be indicative of multi-drug resistance.Additionally, (b)(6) sent the isolate to the center for disease control and prevention (cdc) and the (b)(6) to hold if a comparison was necessary with the previous isolate.(b)(6) actions taken are detailed below: the (b)(6) blood inventory was reviewed to identify any co-components from these 5 donations.Plt collections involved in transfusion #s 2, 3, and 5 all had co-components.It was noted these 3 platelet co-components were transfused to 3 other (b)(6) patients without any transfusion reaction reported to the transfusion service.A review of the charts for these 3 (b)(6) patients had not suggested any concern for a septic reaction.(b)(6) confirmed there was no residual product or returned bags from any of these transfused products that could potentially be used for investigation.Blood suppliers who had collected these products ((b)(6)) were notified per policy and regulatory requirements.Fda was notified of this event due to the recent recommendation for notification of products potentially contaminated with acinetobacter spp.Since the patient had been transfused prior to the positive culture.(b)(6) was notified by the (b)(6) team.Available plasma samples (in edta) obtained from the deceased prior to the positive culture result ((b)(6) 2021 at 13:01h) were retrieved and shipped to (b)(6) for metagenomic sequencing, if required.Furthermore, it was reported (b)(6) county had an apparent number of cases (>100) of acbc with transmission between hospitals.According to (b)(6), the (b)(6) believed the patient had come to (b)(6) with the organism, acbc, from a hospital in (b)(6).It was reported a (b)(6) product was transfused earlier without incident.The product that was of most concern (transfused on the day sample and was obtained for culture) was an arc pathogen reduced platelet unit (prp).A co-component was transfused to another (b)(6) patient without incident.Additionally, another co-component was presumably transfused at an unspecified outside facility without incident (involvement of another arc co-component (#3) was to be confirmed).Residual products/bags were not available.Several other patients on the same medical unit at (b)(6) with the septic patient were screened (perirectal swabs); none were positive for the organism, acbc.Additionally, cases with the same pathogen in the recent past had not been observed at (b)(6).The (b)(6) infection control team concluded that it was very unlikely that intercept pc was the source for acbc.However, a septic transfusion reaction could not be ruled out as rare cases of a.Baumanii contamination of pathogen-reduced platelets had been reported (fda communication, 02-dec-2021).Per ucsf, a septic transfusion reaction ("str") appeared less likely since co-components were transfused to other patients without incident.Per (b)(6), on the cosignee section of the (b)(6) investigation summary, no gram stain or cultures were performed on the products.No residual product was retained by the hospital ((b)(6)) and all products were noted as transfused.Bags were discarded.On (b)(6) 2022, (b)(6) medical center shipped the patient's post-transfusion stab agar sample to the cdc for wgs.Notification of shipment with tracking number was provided to the cdc on 14-jan-2022.The department of health (doh) lab in (b)(6) also requested samples for their testing.It was noted doh organized and arranged that directly with the [(b)(6)] hospital transfusion medical director.(b)(6): on 26-jan-2022, cerus received the following clarification and further details from (b)(6): (b)(6) was notified by (b)(6) of the potential involvement of a (b)(6) "prt" platelet unit in a possible septic transfusion reaction.It was discovered by an infection control review of acinetobacter isolates in platelet recipients.(b)(6) responded to this notice and performed a due diligence assessment of their process for manufacturing "prt" platelets with the intercept system at the facility where the (b)(6) unit was collected.At the time of this report, no specific details (din, donor collection details) on the (b)(6) unit were provided from (b)(6).During the (b)(6) investigation on manufacturing processes, no deficiencies were found in processing "prt".It was reported, no bags from the (b)(6) transfusions were available for culture or returned for evaluation.(b)(6) was in receipt of limited clinical details from (b)(6) of this event which involved other suppliers in addition to (b)(6).However, they were able to confirm that neither the transfusion of (b)(6) blood services "prt" unit to the patient (presumed transfusion #3) in question nor the transfusion of the co-component to a different recipient resulted in a reported adverse reaction in proximity to the transfusions.(b)(6) found nothing to suggest a defect in the cerus supplies or functional issues with the cerus equipment utilized by (b)(6) for pathogen reduction of the transfused units.(b)(6) concluded, given their successful assessment of the manufacturing and delivery of the unit (and co-component), the favorable history of the donor, the timing of the patient's deterioration relative to transfusions, and the other potential sources of acinetobacter, the (b)(6) "prt" platelet unit was extremely unlikely to have been the source of the patient's sepsis.(b)(6) reported this was not considered an adverse event involving (b)(6) use of cerus goods or equipment and noted reporting was not warranted.As a result, (b)(6) felt it was not warranted, nor appropriate for them to complete the form (frm 00785) provided by cerus.(b)(6): on 28-jan-2022, cerus received the following preliminary investigations from the arc: the (b)(6) deemed the event to be a very low probability to be associated with the transfusion.The (b)(6) confirmed this conclusion was found by both the (b)(6) team and the clinical team (presumed (b)(6)).Subsequently, the (b)(6) noted the following information had been received from "the customer": "(b)(6) thinks that patient came to (b)(6) with the organism from a hospital (b)(6).(b)(6) ha[d] >100 cases of this organism with transmission between hospitals.The patient came in with a decubitus ulcer that may have been colonized but not infected at the time of admission.There [were] no cultures from this wound, so there must have been no clinical suspicion."based on this, (b)(6) infection control team believed that blood product was unlikely to be the source of acbc identified in the patient.The (b)(6) took the following immediate action and gained control of the following co-components: din # (b)(6) (manufactured and distributed by (b)(4)) e8341v00 - reverse notification" (implicated unit: co-component 1, transfusion#5, transfused on (b)(6) 2021 09:07h).E8342v00 - expired unit/084ucsfpa - issued/transfused on (b)(6) 2021 [?]'2346" no reaction reported per (b)(6)/cls.Cwa 05-jan-2022."2255"(co-component 2).E7646v00 - plasma quarantined in-house.E7648v00 - plasma shipped to (b)(6) med ctr, placed in quar din # (b)(6) (irradiated rbc, transfusion# 4, manufactured and distributed by (b)(4), transfused on (b)(6) 2021 20:38h).E0336v00 reverse notification.E5201v00 - frac plasma shipped to (b)(6).E3587v00 - (b)(6) cryo pool shipped to (b)(6) med ctr 084muir, placed in quar.Din # (b)(6) (manufactured in (b)(4) and distributed to (b)(4).E8342v00 - reverse notification (co-component#2, transfusion#2, transfused on (b)(6) 2021 20:34h).E8341v00 - expired unit/084ucsfpa - issued/transfused on (b)(6) 2021 "2322 "to a different patient/ no reaction reported per (b)(6)/cls.Cwa 05-jan-2022 "2255" (co-component#1) e7644v00 - plasma quarantined in-house din # (b)(6).E8342v00 - reverse notification (co-component#2, transfusion#1, transfused on (b)(6) 2021 11:10h).E8341v00 - expired unit/(b)(6) med ctr/per (b)(6) cls transfused on (b)(6) 2021/ no reaction reported.Cwa 06-jan-2022"0026"(co-component#1) e7646v00 - "plasma quarantined in-house".E7648v00 - "plasma quarantined in-house".It was reported that were no reports of any adverse events from co-components transfused.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, 02-dec-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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Cerus received additional follow up information on this event on 01-mar-2022, 11-mar-2022, 31-mar-2022.Illuminator serial #: (b)(6).Further information on the initial report was received from dr.(b)(6), md, transfusion medicine director at (b)(6) medical center & (b)(6) hospital and (b)(6) hospital tissue banks, dr.(b)(6), md, ph.D., director at (b)(6) laboratory, (b)(6), (b)(6) blood services, and from (b)(6), (b)(6), md, phd, chief medical officer at (b)(6), and (b)(6), md, (b)(6) on 23-jan-2022, 26-jan-2022, 28-jan-2022, 01-mar-2022, 11-mar-2022, and 31-mar-2022.Updates to arc collection information (revised and new information): it was reported this unit was manufactured and distributed from the (b)(6).The sample was collected from a male, first-time donor (date of birth (dob): (b)(6) 2004) who had answered "no" to all risk questions.On (b)(6) 2021, a donation of apheresis platelets was collected for the intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated, pas intersol lot# fm21i24030, fk kit lot# fa21j11226, arc blood product code# e8342, din# (b)(4), set lot #ce21g05l71).It was reported this unit was manufactured and distributed from the (b)(6).The sample was collected from a male donor (dob: (b)(6) 1951).The donor had 12 donations on record with no previous involvement in "rc".The donor had reported having a left knee replacement over 7 years ago, and a dental implant 3 years ago (overall q3).This unit was treated with large volume (lv) processing set, illuminated with intercept illuminator serial number (b)(6) on (b)(6) 2021 from 07:49h - 07:54h and was split into two co-components.Co-component #2, e8342v00, which was transfused to the patient on (b)(6) 2021 at 11:10h (transfusion#1) and co-component #1 e8241v00 was transfused to another patient on (b)(6)2021 without any reported transfusion reactions (tr).The treatment report showed successful illumination with no indication of illuminator malfunction or irregularities.On the same day, a donation of apheresis platelet was collected for the intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated, pas intersol lot# fm21h25047, fk kit lot# fa21i16184, arc blood product code: e8342, din# (b)(4), set lot# ce21g05l71).It was reported this unit was manufactured from the arc pacific northwest and distributed by (b)(6).The sample was collected from a female donor (dob: (b)(6) 1983).The donor had (b)(4)donations on record with no previous involvement in "rc".The donor had reported having a small needlepoint of scar tissue (overall q1).This unit was treated with large volume (lv) processing set, illuminated with intercept illuminator serial number (b)(6) on (b)(6) 2021 from 07:27h - 07:33h and was split into two co-components.Co-component #2, was transfused to the patient on (b)(6) 2021 at 20:34h (transfusion #2), co-component #1 e8341v00, was transfused to another patient on (b)(6) 2021 without any reported tr.The treatment report showed successful illumination with no indication of illuminator malfunction or irregularities.On (b)(6) 2021, a donation of apheresis platelet was collected for the implicated intercept pc (paspllrpr1 plt, leukocytes reduced, psoralen treated, pas intersol lot# fm21g15032, fk kit lot# fa21j11226, arc blood product code: e8341, din# (b)(4), set lot# ce21g05l71, intercept product code: int2230b).The implicated intercept pc was from the arc northern california.The sample was collected from an a positive, female donor (dob: (b)(6) 1971).The donor had (b)(4) donations on record with no previous involvement in "rc".The donor had reported having a dental crown (q7), and reported she had been "stuck" in two different spots on the same arm (overall q2).The implicated unit was treated with large volume (lv) processing set, illuminated with intercept illuminator serial number (b)(6) from 19:46h - 19:53h and was split into two co-components.Co-component #1, was transfused to the patient on (b)(6) 2021 at 09:07h (transfusion #5), and the co- component #2, e8342v00 was transfused to another patient on (b)(6) 2021 as stated below under arc investigation section without any reported tr.The treatment report showed successful illumination with no indication of illuminator malfunction or irregularities.All donors had been temporarily deferred per arc procedures.Vitalant blood services collection information (revised information): on an unreported date, a non-implicated intercept pc was also collected from vitalant blood donation and transfused to the patient on (b)(6) 2021 at 23:36h (e8332, din# (b)(4)).Details regarding this collection and donor information were not reported.Patients clinical course: (new information)- on (b)(6) 2021, prior to the patient's transfusions, his blood was cultured.After day 6, the culture had no growth.(revised information)- on (b)(6) 2022 at 00:48h, the preliminary blood culture (bc) results showed gram negative, isolated rods that were identified as carbapenem resistant acinetobacter baumanii complex (crab).Updates to (b)(6) investigations: (new information)- on (b)(6) 2022, (b)(6) notified cerus that the (b)(6) department of health ((b)(6)) assisted with the wgs testing of the isolate from the patient in this case.(b)(6)communicated to (b)(6) infection control team that the wgs matched another (b)(6) case who was hospitalized at another unspecified local hospital.It was reported that both cases were "imported" and they were hospitalized at the same hospital in (b)(6) as the patient in this case.As a result, (b)(6) had conclusively ruled out platelets as a source of contamination, and had concluded their investigation of this case.Updates to arc investigations : (new information)- the patient came in with a decubitus ulcer that may have been colonized but not infected at the time of admission.There were no cultures from this wound, so there must have been no clinical suspicion." based on this, arc infection control team believed that a blood product was unlikely to be the source of (b)(6) identified in the patient.Dr.(b)(6), agreed that an str could not be ruled out, but that the str appeared less likely since the co-components were transfused without incident.A transfusion source was not confirmed, and no donor was implicated.All (b)(4) donors involved in this case were assessed for sepsis risks between (b)(6) 2022 and (b)(6) 2022.None of their responses suggested they were the sources of the organism.On (b)(6) 2022, dr.(b)(6) concluded there was no clear evidence of a transfusion reaction in this patient.This appeared to be a case of a positive blood culture in a terminally ill patient who was dnr at the time of transfusion.It was reported from the clinical summary, that during the course of his (b)(6) hospitalization the patient had ongoing sepsis physiology, encephalopathy, and generalized weakness, was improving on steroids/modified rcep.On [(b)(6) 2021] early [morning] the patient experienced acute gi bleeding with hypotension and tachycardia and received a unit of pathogen-reduced platelets at 09:07h.At 13:01h, 2 central blood cultures were drawn.In the afternoon his condition deteriorated further, and he developed dyspnea, hypoxia, tachycardia, hypotension, and fever, so was transferred to the icu for further management and monitoring." on (b)(6) 2022, dr.(b)(6) provided her the final assessment for this case.It was reported as coded "p2", and she requested the donors to be reinstated, and the quarantined products to be released.Additionally, an update from dr.(b)(6) read: "per communication from (b)(6) to our hospital infection control team, wgs matched the other (b)(6) 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." on (b)(6) 2022, the donors were reinstated.The arc took the following immediate action and gained control of the following co-components: din# (b)(4) (manufactured and distributed by (b)(6)) 1.E8341v00 - reverse notification" (implicated unit: co-component 1, transfusion #5, transfused on (b)(6) 2021 09:07h), reported as involved in the possible septic reaction.3.E7646v00 - plasma quarantined in-house per (b)(6) - discarded as broken and rejected on (b)(6) 2022.4.E7648v00 - plasma shipped to (b)(6) ctr, placed in quarantine per arc request.Per dr.(b)(6) not required to be returned.Din# (b)(4) (irradiated rbc, transfusion# 4, manufactured and distributed by(b)(6), transfused on (b)(6) 2021 20:38h) 1.E0336v00 reverse notification, reported as involved in the possible septic reaction.2.E5201v00 - plasma shipped to baxalta (a fractionator) - not transfusable.Per (b)(6) - destroyed upon notification.3.E3587v00 - (b)(4) cryo pool shipped to (b)(6) med ctr 084muir, placed in quar, distributed and quarantined per arc request.Per dr.(b)(6) - not required to be returned.Din# (b)(4) (manufactured in pacific nw and distributed to (b)(6) 1.E8342v00 - reverse notification (co-component2, transfusion2, transfused on (b)(6) 2021 20:34h), reported as involved in the possible septic reaction.3.E7644v00 - plasma quarantined in-house- released into inventory.Din# (b)(4) (manufactured and distributed by (b)(6)) 1.E8342v00 - reverse notification (co-component #2, transfusion #1, transfused on (b)(6) 2021 11:10h), reported as involved in the possible septic reaction.3.E7646v00 - plasma quarantined in-house and was discarded as broken on (b)(6) 2022.4.E7648v00 - plasma quarantined in-house and was discarded as broken on (b)(6) 2022.On (b)(6) 2022, cerus received the final arc investigation.On unreported dates, observations of the collection staff and record review, manufacturing staff and record review, and pathogen reduction review were completed by arc quality assurance.No concerns were noted and procedures were completed as expected.A fatality report was sent to the fda; however, the arc had not received a copy of the patient's fatality report sent.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.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.
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