MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT

Model Number 80300

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Hematuria (2558)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer performed a double platelet donation and the collection procedure was fluent and the donor's status was good during the run.On the next day of platelet donation, the patient developed bleeding gums and hematuria.Per the customer, pre-donation process showed nothing abnormal and the door qualified as available for donation.The donor went to hospital on (b)(6) 2023, the preliminary clinical diagnosis was "coagulant function abnormality".It is unknown at this time if medical intervention was required for this event.Patient id is not available at this time.The platelet collection set is not available for return because it was discarded by the customer.

Event Description

The customer performed a double platelet donation and the collection procedure was fluent and the donor's status was good during the run.On the next day of platelet donation, the patient developed bleeding gums and hematuria.Per the customer, pre-donation process showed nothing abnormal and the door qualified as available for donation.The donor went to hospital on (b)(6) 2023, the preliminary clinical diagnosis was "coagulant function abnormality".It is unknown at this time if medical intervention was required for this event.The customer declined to provide the patient identifier.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (7.4 in 10,000) compared with plateletpheresis (5.2 in 10,000) and double rbc unit collections (3.3 in 10,000).Reactions that needed medical care after the donor left the donation site occurred in roughly 3 in 10,000 donations.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Event Description

The customer performed a double platelet donation and the collection procedure was fluent and the donor's status was good during the run.On the next day of platelet donation, the patient developed bleeding gums and hematuria.Per the customer, pre-donation process showed nothing abnormal and the door qualified as available for donation.The donor went to hospital on (b)(6) 2023, the preliminary clinical diagnosis was "coagulant function abnormality".It is unknown at this time if medical intervention was required for this event.The customer declined to provide the patient identifier.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (7.4 in 10,000) compared with plateletpheresis (5.2 in 10,000) and double rbc unit collections (3.3 in 10,000).Reactions that needed medical care after the donor left the donation site occurred in roughly 3 in 10,000 donations.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed the donor height and weight information was entered into trima as reported.Analysis showed one ¿draw pressure too low¿ alert was raised shortly after the donor was connected and the ¿start draw¿ button was pressed.There were no additional alerts raised throughout the procedure nor any operator adjustments made.The draw flow from the donor was automatically increased 6 times during the procedure due to good venous access during the collection.Analysis of the run data file confirmed the ac infusion rate and return flow rates remained below the configured maximum limits.The end of run summary reported the total ac used was 387ml, with 293ml of ac returned to the donor.There is no evidence or suspicion of device malfunction based on the run data file analysis.Root cause: a root cause assessment was performed for this complaint.A definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (7.4 in 10,000) compared with plateletpheresis (5.2 in 10,000) and double rbc unit collections (3.3 in 10,000).Reactions that needed medical care after the donor left the donation site occurred in roughly 3 in 10,000 donations.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed the donor height and weight information was entered into trima as reported.Analysis showed one ¿draw pressure too low¿ alert was raised shortly after the donor was connected and the ¿start draw¿ button was pressed.There were no additional alerts raised throughout the procedure nor any operator adjustments made.The draw flow from the donor was automatically increased 6 times during the procedure due to good venous access during the collection.Analysis of the run data file confirmed the ac infusion rate and return flow rates remained below the configured maximum limits.The end of run summary reported the total ac used was 387ml, with 293ml of ac returned to the donor.There is no evidence or suspicion of device malfunction based on the run data file analysis.Investigation is in process, a follow-up report will be provided.

Event Description

The customer performed a double platelet donation and the collection procedure was fluent and the donor's status was good during the run.On the next day of platelet donation, the patient developed bleeding gums and hematuria.Per the customer, pre-donation process showed nothing abnormal and the door qualified as available for donation.The donor went to hospital on (b)(6) 2023, the preliminary clinical diagnosis was "coagulant function abnormality".It is unknown at this time if medical intervention was required for this event.The customer declined to provide the patient identifier.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT,PLASMA,ISBT
• 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: 16913181
• MDR Text Key: 315030225
• Report Number: 1722028-2023-00179
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2023

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: 80300
• Device Catalogue Number: 5803002
• Device Lot Number: 2209125251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/19/2023; 06/30/2023; 07/25/2023
• Supplement Dates FDA Received: 06/27/2023; 07/20/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2022
• 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
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 90 KG