MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC

Model Number 82446

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Date 12/31/2019

Event Type  Death  

Event Description

The journal article, "acquired platelet storage container leaks and contamination with environmental bacteria: a preventable cause of bacterial sepsis", described a retrospective study in which the incidence of contamination and sepsis due to environmental bacteria with culture screened apheresis platelets (ap) in the united states for the period of 2010¿2019 was reviewed.Per the article, review of a manufacturers' records showed 23 us reports of leaks involving 24 containers attributed to post manufacturing damage, at a rate of 44 per million distributed storage containers.Analysis of returned containers showed evidence of scratches, impressions, and/or piercings.Literature review of us hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%¿16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial culture screened ap.Sepsis cases have been reported with culture screened, point-of-issue (poi) tested, or pathogen-reduced ap.The index case (case #1) involved a fatal septic transfusion reaction7 in which the same bacterial strains, including staphylococcus saprophyticus (ss), acinetobacter baumannii complex (acbc), and leclercia adecarboxylata (la), were cultured from the patient and the implicated ap.The ap had been repeatedly inspected visually before transfusion, and no leaks were reported at the blood center or hospital.The storage container was returned to the blood center after the patient experienced a transfusion reaction with ~200 ml of platelet content, and no leaks were macroscopically evident (although culture screening detected the implicated bacteria on the external container surface).Further evaluation by an independent laboratory showed a positive leak test when the container was inflated with air and held under water.On emptying the container, a small ~1 mm scratch could be seen near the base of the spiking port (figure 1a).Microscopy revealed a gouge in the plastic with a hole estimated as <50 mm at its base.The evidence for loss of structural integrity of the container was a plausible conduit for postprocessing contamination by environmental bacteria.A broader review of reported container leaks was conducted.Between january 2019 and july 2020, the container manufacturer distributed processing platelet sets that incorporated 546,310 storage containers in the united states and received 23 reports of 24 storage containers with leaks not attributable to manufacturing cause.In each case, the implicated ap was removed from inventory, not transfused, and not cultured.Culture screening reports from the two largest us blood collection services for various time periods between 2009 and 2016 revealed that environmental bacteria were detected in 7% of confirmed positive cultures, at a relatively low rate of 8.6¿12.5 per million cultures (table 2).These services collect predominantly apheresis ap and utilize the amicus (fresenius kabi, lake zurich, ill) or trima (terumo, lakewood, co) separator technologies.The contaminants were all bacillus spp.Or s.Marcescens strains (table 2).Secondary culture screening of ap previously cultured using the bact/alert (biomerieux, durham, nc) or ebds (haemonetics, braintree, ma) systems at two large hospital services between 2004 and 2019, similarly detected a small number of bacillus spp.And serratia spp., but also occasionally detected environmental gram-negative acinetobacter spp.And la strains.Secondary point-of-issue (poi) testing of previously culture screened ap detected bacillus spp.But did not detect any ap contaminated with gram-negative environmental bacteria.The article did not specify which adverse events were associated with the manufacturers.Patient information and details were not provided in the article.This is a journal review which evaluated published journals on the incidence of contamination and sepsis due to environmental bacteria with culture screened apheresis platelets for the period of 2010¿2019.A request for specific donor information is not feasible.This report is being filed with mention of patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.The disposable sets are not available for return for evaluation.

Manufacturer Narrative

Investigation: the authors searched the national library of medicine (pubmed.Gov, national center of biotechnology information, bethesda, md) using the keywords: platelets; contamination; bacteria; and sepsis for publications from 2010¿2019.Review of a manufacturers' records showed 23 us reports of leaks involving 24 containers attributed to post manufacturing damage, at a rate of 44 per million distributed storage containers.Analysis of returned containers showed evidence of scratches, impressions, and/or piercings.Literature review of us hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%¿16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial culture screened ap.Sepsis cases have been reported with culture screened, point-of-issue (poi) tested, or pathogen-reduced ap.Per the article, "six containers, five of which were reported by hospitals, showed evidence of scratches consistent with damage inflicted by platelet agitators, that could occur if the containers were squeezed between shelves or between a shelf and the incubator walls with repetitive reciprocal motion leading to container damage.Four container leaks described in three reports by blood centers had holes or cuts associated with imprints into the plastic, compatible with contact with a foreign object with applied pressure, leading to damage.In a pair of cases reported by a blood center, the imprint was consistent with the outline of a plastic hemostatic clip used to stop flow from one bag to another.These cases suggest improper folding or stacking of platelet containers with a foreign object or the clip situated between the containers and applied pressure.One case reported by a hospital described a pin hole leak in the plastic sheeting.Microscopic examination revealed a cored-out hole compatible with a needlestick injury in one sheet only underneath the blood center's label, suggesting injury before labeling.In 13 reports, the containers were not returned and the damage could not be assessed; however, five cases described the leaks as being related to the ports, four related to a seam, three had pinhole leaks in the sheeting, and one was not described.On the assumption that loss of structural integrity of the container predisposes the ap to postprocessing environmental contamination, a literature review was performed to assess how often environmental bacteria were found contaminating ap or were involved in septic reactions.Nine published reports describing the us experience met the inclusion and exclusion criteria (table 2).These predate the widespread use of platelet pathogen reduction technologies and the use of platelet additive solutions in the united states." according to the aabb circular of information for the use of human blood components (revised 2017), bacterial sepsis occurs rarely but can cause acute, severe, sometimes life-threatening effects.Onset of high fever (>2 c or > 3.5 f increase in temperature), severe chills, hypotension, or circulatory collapse during or shortly after transfusion should suggest the possibility of bacterial contamination and/or endotoxin reaction in the transfused products.Although platelet components stored at room temperature have been implicated most frequently, previously frozen components thawed by immersion in a water bath and red cell components stored for several weeks at 1 to 6 c have also been implicated.Although most platelet components are controlled for bacterial contamination, this does not completely eliminate the risk.Per internal sterility lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Manufacturer Narrative

This report is being filed to provided additional information in h.6 and h.10 and corrected information in h.1.Investigation: the authors searched the national library of medicine (pubmed.Gov, national center of biotechnology information, bethesda, md) using the keywords: platelets; contamination; bacteria; and sepsis for publications from 2010¿2019.Review of a manufacturers' records showed 23 us reports of leaks involving 24 containers attributed to post manufacturing damage, at a rate of 44 per million distributed storage containers.Analysis of returned containers showed evidence of scratches, impressions, and/or piercings.Literature review of us hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%¿16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial culture screened ap.Sepsis cases have been reported with culture screened, point-of-issue (poi) tested, or pathogen-reduced ap.Per the article, "six containers, five of which were reported by hospitals, showed evidence of scratches consistent with damage inflicted by platelet agitators, that could occur if the containers were squeezed between shelves or between a shelf and the incubator walls with repetitive reciprocal motion leading to container damage.Four container leaks described in three reports by blood centers had holes or cuts associated with imprints into the plastic, compatible with contact with a foreign object with applied pressure, leading to damage.In a pair of cases reported by a blood center, the imprint was consistent with the outline of a plastic hemostatic clip used to stop flow from one bag to another.These cases suggest improper folding or stacking of platelet containers with a foreign object or the clip situated between the containers and applied pressure.One case reported by a hospital described a pin hole leak in the plastic sheeting.Microscopic examination revealed a cored-out hole compatible with a needlestick injury in one sheet only underneath the blood center's label, suggesting injury before labeling.In 13 reports, the containers were not returned and the damage could not be assessed; however, five cases described the leaks as being related to the ports, four related to a seam, three had pinhole leaks in the sheeting, and one was not described.On the assumption that loss of structural integrity of the container predisposes the ap to postprocessing environmental contamination, a literature review was performed to assess how often environmental bacteria were found contaminating ap or were involved in septic reactions.Nine published reports describing the us experience met the inclusion and exclusion criteria (table 2).These predate the widespread use of platelet pathogen reduction technologies and the use of platelet additive solutions in the united states." according to the aabb circular of information for the use of human blood components (revised 2017), bacterial sepsis occurs rarely but can cause acute, severe, sometimes life-threatening effects.Onset of high fever (>2 c or > 3.5 f increase in temperature), severe chills, hypotension, or circulatory collapse during or shortly after transfusion should suggest the possibility of bacterial contamination and/or endotoxin reaction in the transfused products.Although platelet components stored at room temperature have been implicated most frequently, previously frozen components thawed by immersion in a water bath and red cell components stored for several weeks at 1 to 6 c have also been implicated.Although most platelet components are controlled for bacterial contamination, this does not completely eliminate the risk.Per internal sterility lab documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

The journal article, "acquired platelet storage container leaks and contamination with environmental bacteria: a preventable cause of bacterial sepsis", described a retrospective study in which the incidence of contamination and sepsis due to environmental bacteria with culture screened apheresis platelets (ap) in the united states for the period of 2010¿2019 was reviewed.Per the article, review of a manufacturers' records showed 23 us reports of leaks involving 24 containers attributed to post manufacturing damage, at a rate of 44 per million distributed storage containers.Analysis of returned containers showed evidence of scratches, impressions, and/or piercings.Literature review of us hemovigilance data revealed that environmental bacteria comprised 7% of confirmed positive primary bacterial culture screens, were responsible for 14%¿16% of reported septic, and 8 of 28 (29%) fatal reactions with bacterial culture screened ap.Sepsis cases have been reported with culture screened, point-of-issue (poi) tested, or pathogen-reduced ap.The index case (case #1) involved a fatal septic transfusion reaction7 in which the same bacterial strains, including staphylococcus saprophyticus (ss), acinetobacter baumannii complex (acbc), and leclercia adecaboxylata (la), were cultured from the patient and the implicated ap.The ap had been repeatedly inspected visually before transfusion, and no leaks were reported at the blood center or hospital.The storage container was returned to the blood center after the patient experienced a transfusion reaction with ~200 ml of platelet content, and no leaks were macroscopically evident (although culture screening detected the implicated bacteria on the external container surface).Further evaluation by an independent laboratory showed a positive leak test when the container was inflated with air and held under water.On emptying the container, a small ~1 mm scratch could be seen near the base of the spiking port (figure 1a).Microscopy revealed a gouge in the plastic with a hole estimated as <50 ¿m at its base.The evidence for loss of structural integrity of the container was a plausible conduit for postprocessing contamination by environmental bacteria.A broader review of reported container leaks was conducted.Between january 2019 and july 2020, the container manufacturer distributed processing platelet sets that incorporated 546,310 storage containers in the united states and received 23 reports of 24 storage containers with leaks not attributable to manufacturing cause.In each case, the implicated ap was removed from inventory, not transfused, and not cultured.Culture screening reports from the two largest us blood collection services for various time periods between 2009 and 2016 revealed that environmental bacteria were detected in 7% of confirmed positive cultures, at a relatively low rate of 8.6¿12.5 per million cultures (table 2).These services collect predominantly apheresis ap and utilize the amicus (fresenius kabi, lake zurich, ill) or trima (terumo, lakewood, co) separator technologies.The contaminants were all bacillus spp.Or s.Marcescens strains (table 2).Secondary culture screening of ap previously cultured using the bact/alert (biomerieux, durham, nc) or ebds (haemonetics, braintree, ma) systems at two large hospital services between 2004 and 2019, similarly detected a small number of bacillus spp.And serratia spp., but also occasionally detected environmental gram-negative acinetobacter spp.And la strains.Secondary point-of-issue (poi) testing of previously culture screened ap detected bacillus spp.But did not detect any ap contaminated with gram-negative environmental bacteria.The article did not specify which adverse events were associated with the manufacturers.Patient information and details were not provided in the article.This is a journal review which evaluated published journals on the incidence of contamination and sepsis due to environmental bacteria with culture screened apheresis platelets for the period of 2010¿2019.A request for specific donor information is not feasible.This report is being filed with mention of patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.The disposable sets are not available for return for evaluation.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15337307
• MDR Text Key: 305608200
• Report Number: 1722028-2022-00291
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other