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U.S. Department of Health and Human Services

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

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TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET Back to Search Results
Catalog Number 4824462
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Chest Pain (1776); Syncope/Fainting (4411)
Event Date 08/13/2023
Event Type  malfunction  
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The run file does not definitively identify when specifically, the donor or the ac were prematurely connected.The file does show that the trima accel had not yet displayed the 'connect donor' screen, nor had it displayed the 'connect ac' screen at the time of the alarm due to the fact that the system was still conducting its self-testing.Based on the available information, it cannot be ruled out that both air and ac may have been returned to the donor due to the unprompted donor connection.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The customer history report indicates no further related issues have been reported for this customer.Correction: the customer was offered retraining but they informed clinical support the relevant operator was currently under suspension.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported to terumo bct customer support that during a triple platelet procedure a donor experienced a severe reaction within the first few minutes.Per the customer, it is possible that the donor was connected to the device prior to the ac prime.The donor experienced chest pains and passed out, but refused further care or to go to hospital.No further information was provided by the customer.The platelet collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.10.Investigation: the run data file (rdf) was analyzed for this event.The run file does not definitively identify when specifically, the donor or the ac were prematurely connected.The file does show that the trima accel had not yet displayed the 'connect donor' screen, nor had it displayed the 'connect ac' screen at the time of the alarm due to the fact that the system was still conducting its self-testing.Based on the available information, it cannot be ruled out that both air and ac may have been returned to the donor due to the unprompted donor connection.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The customer history report indicates no further related issues have been reported for this customer.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcaemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, light-headedness, shivering, and tremors.Severe hypocalcaemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcaemia escalates and is not corrected.Correction: the customer was offered retraining but they informed clinical support the relevant operator was currently under suspension.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported to terumo bct customer support that during a triple platelet procedure a donor experienced a severe reaction within the first few minutes.Per the customer, t is possible that the donor was connected to the device prior to the ac prime.The donor experienced chest pains and passed out, but refused further care or to go to hospital.No further information was provided by the customer.The platelet collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The run file does not definitively identify when specifically, the donor or the ac were prematurely connected.The file does show that the trima accel had not yet displayed the 'connect donor' screen, nor had it displayed the 'connect ac' screen at the time of the alarm due to the fact that the system was still conducting its self-testing.Based on the available information, it cannot be ruled out that both air and ac may have been returned to the donor due to the unprompted donor connection.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The customer history report indicates no further related issues have been reported for this customer.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcaemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, light-headedness, shivering, and tremors.Severe hypocalcaemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcaemia escalates and is not corrected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Medical safety team concluded that based on the limited clinical and investigation findings of this report, the trima accel device and tubing set performed as intended, there were no suggested device failures, malfunctions, mislabelling, improper or inadequate design or manufacturing errors that contributed to or caused the signs/symptoms experienced by the patient in this report.There is a user error as the donor was connected too early in the procedure.Correction: the customer was offered retraining but they informed clinical support the relevant operator was currently under suspension.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported to terumo bct customer support that during a triple platelet procedure a donor experienced a severe reaction within the first few minutes.Per the customer, it is possible that the donor was connected to the device prior to the ac prime.The donor experienced chest pains and passed out, but refused further care or to go to hospital.No further information was provided by the customer.The platelet collection set is not available for return because it was discarded by the customer.
 
Event Description
The customer reported to terumo bct customer support that during a triple platelet procedure a donor experienced a severe reaction within the first few minutes.Per the customer, it is possible that the donor was connected to the device prior to the ac prime.The donor experienced chest pains and passed out, but refused further care or to go to hospital.No further information was provided by the customer.The platelet collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The run file does not definitively identify when specifically, the donor or the ac were prematurely connected.The file does show that the trima accel had not yet displayed the 'connect donor' screen, nor had it displayed the 'connect ac' screen at the time of the alarm due to the fact that the system was still conducting its self-testing.Based on the available information, it cannot be ruled out that both air and ac may have been returned to the donor due to the unprompted donor connection.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The customer history report indicates no further related issues have been reported for this customer.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcaemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, light-headedness, shivering, and tremors.Severe hypocalcaemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcaemia escalates and is not corrected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The terumo bct medical safety team concluded that based on the limited clinical and investigation findings of this report, the trima accel device and tubing set performed as intended, there were no suggested device failures, malfunctions, mislabelling, improper or inadequate design or manufacturing errors that contributed to or caused the signs/symptoms experienced by the patient in this report.There is a user error as the donor was connected too early in the procedure.Correction: the customer was offered retraining but they informed clinical support the relevant operator was currently under suspension.Root cause: a root cause assessment was performed for this complaint.The root cause for the suspected air to donor potential that may have resulted in the reaction was determined to be an operator error where they connected the donor too soon.Possible causes for a suspected citrate reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure relating to the operator error where the donor was connected too soon.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
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 Key17712492
MDR Text Key322981833
Report Number1722028-2023-00299
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK190332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2024
Device Catalogue Number4824462
Device Lot Number2304246242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received09/08/2023
Supplement Dates Manufacturer Received12/05/2023
01/02/2024
02/22/2024
Supplement Dates FDA Received12/12/2023
01/05/2024
02/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age48 YR
Patient SexMale
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