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Cerus is reporting this case of a non-serious adverse event because of similar cases involving environmental bacterial contamination of platelet components that had been successfully treated with the intercept blood system for platelets.Febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction]; suspected septic transfusion reaction [pt: transmission of infectious agent via product].Date cerus received: 26-jan-2021, 27-jan-2021, 29-jan-2021, 08-feb-2021, 12-feb-2021 (in), 25-feb-2021, 18-mar-2021 (nsfu1), 26-mar-2021 (nsfu2), 15-sep-2021 (fu3).The patient involved in this report is a (b)(6) male.Product complaint #: (b)(4).Product code #: int2130b.Set lot #: ce20g08l71.Illuminator serial #: (b)(4).On (b)(6) 2021, a spontaneous non-serious adverse event report ((b)(4)) of a febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction] and a suspected septic transfusion reaction [pt: transmission of infectious agent via product] were reported to cerus.The initial report from (b)(6) (reporter became aware of event on 09-jan-2021) was to notify cerus of a transfusion reaction in a patient, involving an intercept-treated platelet concentrate (pc) transfusion at (b)(6) hospital in (b)(6), and to report a positive culture obtained from the same intercept pc transfusion bag.Initially, the event was characterized as "possible contaminated pr unit that caused a transfusion reaction." further information on the initial report was received from dr.(b)(6) and (b)(6) on 27-jan-2021 (during a tc with cerus), and on 29-jan-2021, 08-feb-2021, 12-feb-2021 (via form (b)(4)), 25-feb-2021,18-mar-2021, and 26-mar-2021 note: in conversation with dr.(b)(6) on (b)(6) 2021 it was initially suggested that there was a possible bacterial contamination of a pr unit that caused a transfusion reaction, however, a febrile non-hemolytic transfusion reaction (fnhtr), which would be an expected event for either conventional or intercept platelets, was also considered as a possible explanation for the tr of temperature increase of >2 °f following the intercept platelet transfusion.On (b)(6) 2021, a form (b)(4) was received from dr.(b)(6) with the primary event identified as fnhtr and a questionable unconfirmed second event of suspected septic transfusion reaction.Platelet collection: on (b)(6) 2021, a single platelet apheresis (leukocytes reduced, psoralen treated) donation was collected at (b)(6).On (b)(6) 2021, the implicated unit ((b)(4)) was treated with an intercept blood system single volume storage (sv) processing set.From 04:12h - 04:17h, the implicated unit ((b)(4)) 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.Patient's clinical course: this report involves a (b)(6) patient, who experienced a non-serious event of febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction] following a transmission of intercept treated platelet component.The patient's current conditions include wilms tumor.The patient did not have a documented history of transfusion reactions prior to the reported events.On (b)(6) 2021 08:40h, the patient's pre-transfusion vitals were as follows: temperature: 98.6° fahrenheit.Blood pressure: 101/52 mmhg.From 08:40h - 09:45h, the patient received approximately half of a unit of 2-day stored intercept platelets ((b)(4)) via central line to treat thrombocytopenia.During transfusion, the patient experienced an increase in body temperature of >2°fahrenheit.The patient was being transfused in an outpatient clinic for more than one hour when the temperature increase was observed.The transfusion was stopped due to the transfusion reaction.The patient received acetaminophen to treat the fever.After the transfusion reaction, blood cultures were drawn.All symptoms resolved shortly thereafter, and no additional symptoms were reported.The patient was sent home.At an unspecified time while in the outpatient clinic, the patient also received a red blood cell (rbc) transfusion prior to the pc transfusion.On the same day, a sample was taken from the intercept platelet transfusion bag ((b)(4)) to perform a culture and the transfusion bag was sent back to transfusion services with "a lot of product" left in it.At 09:45h, the patient's post-transfusion vitals were as follows: temperature: 101.1° fahrenheit.Blood pressure: 112/79 mmhg.On (b)(6) 2021, a positive culture result on a sample taken from the intercept platelet transfusion bag ((b)(4)) was reported to the patient's clinician.The gram stain performed on the culture of the content of the bag detected gram-positive and gram-negative rod-shaped organisms.A subculture was performed by (b)(6).Using matrix-assisted laser desorption ionization time-of-flight (maldi-tof), the organisms were identified as bacillus megaterium (gram-positive rod) and acinetobacter radioresistans (gram-negative rod).On an unknown date, upon confirmation of the positive culture test results from the intercept platelet transfusion bag, the patient's parents were notified by the memorial hospital and the child presented to the emergency room (er) of an unknown local hospital.Blood cultures were performed, and the patient was prescribed new antibiotics.It was reported that the patient did not appear to be septicemic.The result of the patient's blood cultures before and after the antibiotics was later reported as negative.Note: only after positive platelet transfusion bag culture results were confirmed, the reporter contacted cerus to report the suspected event (not upon temperature increase in the patient after transfusion).On an unknown date, the patient presented back to the memorial hospital of south bend, in.The patient was reportedly "admitted", with no signs or symptoms of infection and given unspecified antibiotics.Subsequently, he was sent home and was reported to be clinically doing well.Additional blood cultures were obtained at that time, later reported to be negative.The outcome of the event of febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction] was considered recovered/resolved.Cerus investigations: on (b)(6) 2021, cerus microbiology received samples and implicated platelet unit ((b)(4); product code: e8331v00) from (b)(6) (which was shipped to sbmf by (b)(6)).There was noted to be a significant amount of platelet concentrate that leaked out of the storage container into the (b)(6) bag.On (b)(6) 2021, the cerus quality assurance director and cerus cmo performed an inspection of the single platelet storage container ((b)(4); product code: e8331v00) in a biological safety cabinet.The exterior of the container was dried and wiped down with ethanol to decontaminate the bag.It was noted that both ports were opened.On the middle outlet port, the spike and transfusion line were in place, however the roller clamps were not closed on the transfusion line, allowing the contents of the storage container to exit into the containment packaging.Parafilm was wrapped around the second outlet port to close the port, as the spike was removed.Upon inspection of the ports, no damage was observed.Fluid was observed exiting the port, which was "closed" with parafilm due to an inadequate seal.A small scuff (0.5 mm) was seen on the sheeting and seal of the bag.Further inspection showed no evidence of liquid leak through this lesion when approximately 250 ml of water was added to the container and a low pressure was applied manually to the fluid in the bag.No further testing was performed.On (b)(6) 2021, cerus microbiology department received the bacterial stabs of the positive culture results obtained by (b)(6).Growth was observed from the bacterial stabs.On (b)(6) 2021, sequencing data from the bacterial strains was received from (b)(6), confirming the original organisms (bacillus megaterium and acinetobacter radioresistans) identified by (b)(6) on (b)(6) 2021.On the same day, bacteria were isolated from the implicated platelet unit ((b)(4); product code: e8331v00) by cerus bacteriology and sent to the sequencing lab.On (b)(6) 2021, cerus bacteriology received the final sequencing report of the bacterial strains, from the sequencing lab, as follows: the bacteria were identified as enterococcus durans and bacillus thuringiensis using 16s ribosomal ribonucleic acid (rrna) sequencing and fatty acid methyl esters (fame) analysis.These species were different than the organisms originally identified (bacillus megaterium and acinetobacter radioresistens) by (b)(6).Per cerus bacteriology, it was possible that the platelet unit ((b)(4)); product code: e8331v00) was contaminated at some point during the transport to cerus, as the platelet unit was leaking upon arrival.All relevant information has been obtained and no further information is expected at the time of this report.Reporter assessment: the reporter assessed the event of febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction] as non-serious and probable in relation to intercept platelets but not related to the intercept blood system for platelets device.The severity was assessed as mild.The reporter indicated that the event of febrile non-hemolytic transfusion reaction was an expected event as with transfusion of blood components and was related to the implicated pc transfusion due to a febrile reaction, however there was no evidence that the patient was infected with the bacteria that was cultured from the transfusion bag.The reported event of suspected septic transfusion reaction [pt: transmission of an infectious agent via product] was presented as an alternative to the fnhtr event but was discounted based on the lack of a severe clinical reaction or culture evidence of infection despite multiple blood cultures.Cerus medical assessment: cerus medical reviewer agrees with the reporter that the event of a of febrile non-hemolytic transfusion reaction [pt: febrile nonhaemolytic transfusion reaction] was non-serious.The clinical status of the patient was reported as "no complaints/complications from the patient have been reported".The cerus reviewer considers the event to be mild - to - moderate in severity as the patient was sent home after the tr, after a dose of antipyretic.The cerus medical reviewer considers the causality for the event of febrile non-hemolytic transfusion reaction to be probable in relation to the transfused intercept-treated platelet concentrate, however, not related to the intercept blood system for platelets device.In absence of matching (or any) blood culture positivity, the medical reviewer considers the "suspected septic tr" to be an fnhtr and not sepsis.The source of the positive bacterial cultures from the implicated platelet concentrate is not known.Following subsequent reports of similar cases involving environmental bacterial contamination, it is likely that contamination of the platelet bag occurred at the time of spiking of the container, possibly via bag damage caused by the transfusion canulae at the time of transfusion.The cerus medical reviewer considers the clinical events to be expected according to cerus reportability information.Non-significant follow-up #1 information received on 25-feb-2021 and 18-mar-2021 is incorporated in the above narrative: confirmation of growth from bacterial stabs of the positive culture results obtained by (b)(6).Confirmation of receipt of sequencing data from the bacterial strains, confirming the original organisms previously identified by (b)(6).Non-significant follow-up #2 information received on 26-mar-2021 is incorporated in the above narrative: the final sequencing report of the bacterial strains was received by cerus bacteriology, identifying the bacteria as enterococcus durans and bacillus thuringiensis.It was noted that these species differed from the organisms originally identified (bacillus megaterium and acinetobacter radioresistens) by (b)(6).No further information is expected to be received for the case.Follow up #3 information received on 15-sep-2021 is incorporated in the above narrative: it was decided to submit a report to the regulatory agency based on the fact that additional reports of similar cases involving environmental bacterial contamination were received.It is likely that in this case, a contamination of the platelet bag occurred at the time of spiking of the container, possibly via bag damage caused by the transfusion canulae at the time of transfusion.
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