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

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.

• 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 Key: 17712492
• MDR Text Key: 322981833
• Report Number: 1722028-2023-00299
• Device Sequence Number: 1
• Product Code: GKT
• 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: 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 Date: 04/01/2024
• Device Catalogue Number: 4824462
• Device Lot Number: 2304246242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/02/2024; 02/22/2024
• Supplement Dates FDA Received: 12/12/2023; 01/05/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male