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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLASMA SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLASMA SET Back to Search Results
Catalog Number 5805371
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907)
Event Date 09/23/2021
Event Type  Injury  
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer reported that during a trima collection, the donor experienced an allergic reaction.The donor was admitted to a hospital for the night and then discharged.Per the customer it was judged by the site doctor as anaphylactic shock and no additional details are known.It was reported that this is the donors second donation for apheresis plasma.The customer does not believe this issue is related to trima products (device or disposable).Patient id and weight are not available from the customer.The customer was not able to provide the patient outcome.The platelet collection is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: per follow with the customer, the on-site doctor determined the reaction as anaphylactic shock and details about the extent of medical intervention were unavailable.This was not a first time donor.Per the customer the donor did not experience such a reaction during their first donation on trima.This was the second blood donation for the donor to donate apheresis plasma.The blood center decided to collect only whole blood from the donor from the next time.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer reported that during a trima collection, the donor experienced an allergic reaction.The donor was admitted to a hospital for the night and then discharged.Per the customer it was judged by the site doctor as anaphylactic shock and no additional details are known.It was reported that this is the donors second donation for apheresis plasma.The customer does not believe this issue is related to trima products (device or disposable).Patient id and weight are not available from the customer.The customer was not able to provide the patient outcome.The platelet collection is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: per follow with the customer, the on-site doctor determined the reaction as anaphylactic shock and details about the extent of medical intervention were unavailable.This was not a first time donor.Per the customer the donor did not experience such a reaction during their first donation on trima.This was the second blood donation for the donor to donate apheresis plasma.The blood center decided to collect only whole blood from the donor from the next time.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the donor's physiology and/or donor's sensitivity to the procedure.
 
Event Description
The customer reported that during a trima collection, the donor experienced an allergic reaction.The donor was admitted to a hospital for the night and then discharged.Per the customer it was judged by the site doctor as anaphylactic shock and no additional details are known.It was reported that this is the donors second donation for apheresis plasma.The customer does not believe this issue is related to trima products (device or disposable).Patient id and weight are not available from the customer.The customer was not able to provide the patient outcome.The platelet collection is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL PLASMA 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 Key12856034
MDR Text Key281138316
Report Number1722028-2021-00362
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2023
Device Catalogue Number5805371
Device Lot Number2104184251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2021
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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