| Catalog Number 6212001 |
| Device Problems
Excess Flow or Over-Infusion (1311); Insufficient Information (3190)
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| Patient Problems
Cardiac Arrest (1762); Local Reaction (2035)
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| Event Date 01/31/2024 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation: per the customer the procedure ran for 34 minutes.Following the donor event, the customer captured photos of the device setup and provided these photos to terumo bct.The photos show the rika device in question with the used disposable set still loaded onto the machine.The presence of plasma within the collection bottle is visible, and the donor had been disconnected.The ac bag and saline bag are visibly hung and spiked in the incorrect locations.Photos show that an ac bag, with red bag labeling, is incorrectly connected to the white, saline spike and incorrectly hung on the saline bag pole (right side of the device).A bag of saline with black labeling is incorrectly connected to the red ac spike and incorrectly hung on the ac bag pole.Photo further confirms that the ac bag was misplaced on the saline hook (right side when facing the device) and the saline bag was misplaced on the ac hook.The hardware and equipment mitigations for the dimensions of the saline and ac hooks are visible in the photos provided by the customer.Each uniquely designed hook is mounted on a separate ac and saline pole.The poles have different outer diameters.The ac bag pole (located on the left side, when facing the device) and the saline bag pole (located on the right side, when facing the device).The unique ac and saline pole hooks are permanently capped onto the poles and are not interchangeable.Based on the diameter variations observed in photo confirmation of the placement of the ac bag on the saline bag pole and subsequently saline hook can be made.The disposable rika separation set in question was returned to terumo bct for evaluation.The set was visually inspected for placement of the red and white connectors as well as any other defects, disassemblies or anomalies.The returned separation set contained fluid and had been sealed off to contain the contents and was returned in three parts: returned part no.1 evaluation of the separation set confirmed the set was sealed off at the following four locations to contain the blood within the set: ¿ on the saline line (with part 3 returned but not connected to the separation set) ¿ on the ac line (with part 2 retuned but not connected to the separation set) ¿ on the collect line, just prior to the plasma container connector ¿ below the donor needle connect where the fistula needle had previously been connected the ac tubing was confirmed to have the white stripe to distinguish it from other tubing in the set.This stripe confirmed that the red ac spike was properly attached to the ac pump line tubing.The absence of a white stripe on the saline line tubing was also confirmed and the assembly of the detached, white saline spike could also be made.The returned part evaluation did not identify manufacturing defects and confirmed the returned separation set was assembled per design specifications.Returned part no.S 2 and 3 an empty, detached 250 ml ac bag (4%, sodium citrate) and a partially full, detached 500 ml saline bag (0.9% sodium chloride), were returned along with the disposable set.Although the bags had been detached and sealed off from the set, the configuration of the spikes and the bags were consistent with the photo provided by the customer.Evaluation confirmed the white saline spike was attached to the ac bag, and the red ac spike was attached to the saline bag.In efforts to confirm the quantity of saline and ac returned with the kit, the spikes were removed from the bags, both bags were weighed, and the contents were emptied into separate beakers: saline + bag = 445.4 g saline = 420.9 g residual ac + bag = 20.1 g ac = 0.1 g this confirmed that nearly all the contents from the 250 ml ac bag were not present within the ac bag upon return of the part.Returned part no.3 based on the device design controls of the saline bag pole hook, the ac bag hole was evaluated to determine if the dimensions of the ac bags would allow for placement on the saline bag pole hook.The ac bag hole displayed slight rippling and distortion, indicating that the hole was exposed to atypical stress.The dimensions of the returned ac bag hole were less than the dimension of the saline bag hook.A review of the certificate of compliance shows that the lot has been manufactured according to u.S.Fda quality system regulations and en iso 13485, and met all acceptance criteria for release.A disposable history search of complaints received indicated there were no other reports of similar issues associated with this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The device serial number history report indicates no further related issues have been reported for this device.The customer history report indicates no further related issues have been reported for this customer.Correction: terumo bct offered retraining to the customer in response to this incident.On feb 12, 2024 the customer stated that ¿actions were taken at the center level (retraining on solution importance, handling, and proper connections).From a company wide perspective, csl has initiated a ¿four eyes¿ process where two people must confirm the solutions are properly connected before continuing in a rika procedure.¿ investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that a donor had an adverse citrate reaction which was caused by technician spiking incorrect solutions on a rika device.Per the customer the saline and anticoagulant (ac) were swapped during spike.Per follow up from the customer it was reported that the donor went into cardiac arrest and the center medical staff started cpr measures, utilizing the aed, and ems was called.Cpr was continued until ems arrived; ems took over the care and transported donor to a local hospital.Per the customer the donor was hospitalized and in the icu.Full donor identifier: (b)(6).
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Event Description
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The customer reported that a donor had an adverse citrate reaction which was caused by technician spiking incorrect solutions on a rika device.Per the customer the saline and anticoagulant (ac) were swapped during spike.Per follow up from the customer it was reported that the donor went into cardiac arrest and the center medical staff started cpr measures, utilizing the aed, and ems was called.Cpr was continued until ems arrived; ems took over the care and transported donor to a local hospital.Per the customer the donor was hospitalized and in the icu.Full donor identifier: (b)(6).
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: per the customer the procedure ran for 34 minutes.The type of ac used/concentration of solution was sodium citrate 4% w/v solution 250 ml, lot 23h02sc.The device reported total amount of ac delivered (ml) to donor: 107 ml (as reported by device for ac; donor received saline instead due to the switch).Rinseback began normally, at a flowrate of 120 ml/min.After 205 ml of fluid had been delivered to the donor (donor cells from the channel and approximately 50 ml of ac), the operator decreased the rinseback return flow rate to 60 ml/min.Rinseback continued at a return flow rate of 60 ml/min for the remainder of the procedure.Ac infusion rate (ml/min/l) = volume of ac to donor (ml) / infusion time (min) / donor tbv (l) =(233 ml)/ (6.35 mins) / (3.849 l) = 9.53 ml/min/ltbv.Following the donor event, the customer captured photos of the device setup and provided these photos to terumo bct.The photos show the rika device in question with the used disposable set still loaded onto the machine.The presence of plasma within the collection bottle is visible, and the donor had been disconnected.The ac bag and saline bag are visibly hung and spiked in the incorrect locations.The image was evaluated for proper setup of the disposable set as it pertains to this event (not including accessory solution bags) per the following applicable sections of the rika plasma donation system operator¿s which is accessible to operators at each center.The photos provide evidence that the disposable set (which does not include the accessory solution bags) was properly loaded per operator¿s manual.This confirmation is visible within the photos, as the red ac spike which is assembled by terumo bct on the ac pump line and is located on the left side of the device (when facing the device).Additionally, the white saline spike is visible on the saline line and is located on the right side of the device (when facing the device).Photos show that an ac bag, with red bag labeling, is incorrectly connected to the white, saline spike and incorrectly hung on the saline bag pole (right side of the device).A bag of saline with black labeling is incorrectly connected to the red ac spike and incorrectly hung on the ac bag pole.Photo further confirms that the ac bag was misplaced on the saline hook (right side when facing the device) and the saline bag was misplaced on the ac hook.The hardware and equipment mitigations for the dimensions of the saline and ac hooks are visible in the photos provided by the customer.Each uniquely designed hook is mounted on a separate ac and saline pole.The poles have different outer diameters.The ac bag pole (located on the left side, when facing the device) and the saline bag pole (located on the right side, when facing the device).The unique ac and saline pole hooks are permanently capped onto the poles and are not interchangeable.Based on the diameter variations observed in photo confirmation of the placement of the ac bag on the saline bag pole and subsequently saline hook can be made.The disposable rika separation set in question was returned to terumo bct for evaluation.The set was visually inspected for placement of the red and white connectors as well as any other defects, misassemblies or anomalies.The returned separation set contained fluid and had been sealed off to contain the contents and was returned in three parts: returned part no.1 evaluation of the separation set confirmed the set was sealed off at the following four locations to contain the blood within the set: ¿ on the saline line (with part 3 returned but not connected to the separation set) ¿ on the ac line (with part 2 retuned but not connected to the separation set) ¿ on the collect line, just prior to the plasma container connector ¿ below the donor needle connect where the fistula needle had previously been connected the ac tubing was confirmed to have the white stripe to distinguish it from other tubing in the set.This stripe confirmed that the red ac spike was properly attached to the ac pump line tubing.The absence of a white stripe on the saline line tubing was also confirmed and the assembly of the detached, white saline spike could also be made.The returned part evaluation did not identify manufacturing defects and confirmed the returned separation set was assembled per design specifications.Returned part no.S 2 and 3 an empty, detached 250 ml ac bag (4%, sodium citrate) and a partially full, detached 500 ml saline bag (0.9% sodium chloride), were returned along with the disposable set.Although the bags had been detached and sealed off from the set, the configuration of the spikes and the bags were consistent with the photo provided by the customer.Evaluation confirmed the white saline spike was attached to the ac bag, and the red ac spike was attached to the saline bag.In efforts to confirm the quantity of saline and ac returned with the kit, the spikes were removed from the bags, both bags were weighed, and the contents were emptied into separate beakers: saline + bag = 445.4 g saline = 420.9 g residual ac + bag = 20.1 g ac = 0.1 g this confirmed that nearly all the contents from the 250 ml ac bag were not present within the ac bag upon return of the part.Returned part no.3 based on the device design controls of the saline bag pole hook, the ac bag hole was evaluated to determine if the dimensions of the ac bags would allow for placement on the saline bag pole hook.The ac bag hole displayed slight rippling and distortion, indicating that the hole was exposed to atypical stress.The dimensions of the returned ac bag hole were less than the dimension of the saline bag hook.A review of the certificate of compliance shows that the lot has been manufactured according to u.S.Fda quality system regulations and en iso 13485, and met all acceptance criteria for release.A disposable history search of complaints received indicated there were no other reports of similar issues associated with this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The device serial number history report indicates no further related issues have been reported for this device.The customer history report indicates no further related issues have been reported for this customer.Based on the clinical information provided, terumo bct global medical safety concluded that the rika performed as designed, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.However, there was a user error when the operator switched the ac and saline, which contributed to or caused this adverse event.Correction: terumo bct offered retraining to the customer in response to this incident.On feb 12, 2024 the customer stated that ¿actions were taken at the center level (retraining on solution importance, handling, and proper connections).From a company wide perspective, csl has initiated a ¿four eyes¿ process where two people must confirm the solutions are properly connected before continuing in a rika procedure.¿ corrective action: an internal capa has been initiated to evaluate this event.Root cause: a root cause assessment was performed for ac overinfusion resulting in adverse citrate reactions.The investigation included evaluation of the photo taken of the setup on the day of donation, part evaluation of the returned set, review of design controls and specifications, device log files, as well as documentation in the form of operator¿s manual and training materials.The root cause was determined to be due to an operator or use error where the technician accidentally connected a 250 ml ac bag to the saline line, and a 500 ml saline bag to the ac line during set up.The unintended ac overinfusion event during the rinseback process resulted in the donor experiencing a severe citrate reaction.Based on the clinical information provided, terumo bct global medical safety concluded that the rika performed as designed, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.However, there was a user error when the operator switched the ac and saline, which contributed to or caused this adverse event.
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Event Description
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The customer reported that a donor had an adverse citrate reaction which was caused by technician spiking incorrect solutions on a rika device.Per the customer the saline and anticoagulant (ac) were swapped during spike.Per follow up from the customer it was reported that the donor went into cardiac arrest and the center medical staff started cpr measures, utilizing the aed, and ems was called.Cpr was continued until ems arrived; ems took over the care and transported donor to a local hospital.Per the customer the donor was hospitalized and in the icu.Full donor identifier: (b)(6).
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Investigation: per the customer the procedure ran for 34 minutes.The type of ac used/concentration of solution was sodium citrate 4% w/v solution 250 ml, lot 23h02sc.The device reported total amount of ac delivered (ml) to donor: 107 ml (as reported by device for ac; donor received saline instead due to the switch).Rinseback began normally, at a flowrate of 120 ml/min.After 205 ml of fluid had been delivered to the donor (donor cells from the channel and approximately 50 ml of ac), the operator decreased the rinseback return flow rate to 60 ml/min.Rinseback continued at a return flow rate of 60 ml/min for the remainder of the procedure.Ac infusion rate (ml/min/l) = volume of ac to donor (ml) / infusion time (min) / donor tbv (l) =(233 ml)/ (6.35 mins) / (3.849 l) = 9.53 ml/min/ltbv.Following the donor event, the customer captured photos of the device setup and provided these photos to terumo bct.The photos show the rika device in question with the used disposable set still loaded onto the machine.The presence of plasma within the collection bottle is visible, and the donor had been disconnected.The ac bag and saline bag are visibly hung and spiked in the incorrect locations.The image was evaluated for proper setup of the disposable set as it pertains to this event (not including accessory solution bags) per the following applicable sections of the rika plasma donation system operator¿s which is accessible to operators at each center.The photos provide evidence that the disposable set (which does not include the accessory solution bags) was properly loaded per operator¿s manual.This confirmation is visible within the photos, as the red ac spike which is assembled by terumo bct on the ac pump line and is located on the left side of the device (when facing the device).Additionally, the white saline spike is visible on the saline line and is located on the right side of the device (when facing the device).Photos show that an ac bag, with red bag labeling, is incorrectly connected to the white, saline spike and incorrectly hung on the saline bag pole (right side of the device).A bag of saline with black labeling is incorrectly connected to the red ac spike and incorrectly hung on the ac bag pole.Photo further confirms that the ac bag was misplaced on the saline hook (right side when facing the device) and the saline bag was misplaced on the ac hook.The hardware and equipment mitigations for the dimensions of the saline and ac hooks are visible in the photos provided by the customer.Each uniquely designed hook is mounted on a separate ac and saline pole.The poles have different outer diameters.The ac bag pole (located on the left side, when facing the device) and the saline bag pole (located on the right side, when facing the device).The unique ac and saline pole hooks are permanently capped onto the poles and are not interchangeable.Based on the diameter variations observed in photo confirmation of the placement of the ac bag on the saline bag pole and subsequently saline hook can be made.The disposable rika separation set in question was returned to terumo bct for evaluation.The set was visually inspected for placement of the red and white connectors as well as any other defects, misassemblies or anomalies.The returned separation set contained fluid and had been sealed off to contain the contents and was returned in three parts: returned part no.1 evaluation of the separation set confirmed the set was sealed off at the following four locations to contain the blood within the set: ¿ on the saline line (with part 3 returned but not connected to the separation set) ¿ on the ac line (with part 2 retuned but not connected to the separation set) ¿ on the collect line, just prior to the plasma container connector ¿ below the donor needle connect where the fistula needle had previously been connected the ac tubing was confirmed to have the white stripe to distinguish it from other tubing in the set.This stripe confirmed that the red ac spike was properly attached to the ac pump line tubing.The absence of a white stripe on the saline line tubing was also confirmed and the assembly of the detached, white saline spike could also be made.The returned part evaluation did not identify manufacturing defects and confirmed the returned separation set was assembled per design specifications.Returned part no.S 2 and 3 an empty, detached 250 ml ac bag (4%, sodium citrate) and a partially full, detached 500 ml saline bag (0.9% sodium chloride), were returned along with the disposable set.Although the bags had been detached and sealed off from the set, the configuration of the spikes and the bags were consistent with the photo provided by the customer.Evaluation confirmed the white saline spike was attached to the ac bag, and the red ac spike was attached to the saline bag.In efforts to confirm the quantity of saline and ac returned with the kit, the spikes were removed from the bags, both bags were weighed, and the contents were emptied into separate beakers: saline + bag = 445.4 g saline = 420.9 g residual ac + bag = 20.1 g ac = 0.1 g this confirmed that nearly all the contents from the 250 ml ac bag were not present within the ac bag upon return of the part.Returned part no.3 based on the device design controls of the saline bag pole hook, the ac bag hole was evaluated to determine if the dimensions of the ac bags would allow for placement on the saline bag pole hook.The ac bag hole displayed slight rippling and distortion, indicating that the hole was exposed to atypical stress.The dimensions of the returned ac bag hole were less than the dimension of the saline bag hook.A review of the certificate of compliance shows that the lot has been manufactured according to u.S.Fda quality system regulations and en iso 13485, and met all acceptance criteria for release.A disposable history search of complaints received indicated there were no other reports of similar issues associated with this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The device serial number history report indicates no further related issues have been reported for this device.The customer history report indicates no further related issues have been reported for this customer.Based on the clinical information provided, terumo bct global medical safety concluded that the rika performed as designed, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.However, there was a user error when the operator switched the ac and saline, which contributed to or caused this adverse event.Correction: terumo bct offered retraining to the customer in response to this incident.On feb 12, 2024 the customer stated that ¿actions were taken at the center level (retraining on solution importance, handling, and proper connections).From a company wide perspective, csl has initiated a ¿four eyes¿ process where two people must confirm the solutions are properly connected before continuing in a rika procedure.¿ corrective action: an internal capa has been initiated to evaluate this event.Investigation is in process.A follow-up report will be provided.
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Search Alerts/Recalls
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