MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS

Catalog Number 82383

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

Patient Problems Muscle Weakness (1967); Anxiety (2328)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that at the beginning of a trima donation the donor felt bad.The nurse removed the needle from the donor before the first return, approx.10 seconds after the needle was put in the donor.It was reported that the donor looked as anxiety attack and the donor had antecedent of covid19 few weeks ago, she was weak again.She didn't lose consciousness.The donor was monitored by (b)(6) with blood pressure monitoring, ecg and saturation.Per the customer the intervention was done because the patient could not go home alone.Patient outcome, identifier, age and weight are unknown at this time.The platelet collection set 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

Investigation: the lot number was not provided, therefore, a dhr and disposable history search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to aabb technical manual 16th edition pg 195-196, 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

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

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

Event Description

The customer reported that at the beginning of a trima donation the donor felt bad.The nurse removed the needle from the donor before the first return, approx.10 seconds after the needle was put in the donor.It was reported that the donor looked as anxiety attack and the donor had antecedent of covid19 few weeks ago, she was weak again.She didn't lose consciousness.The donor was monitored by (b)(6) with blood pressure monitoring, ecg and saturation.Per the customer the intervention was done because the patient could not go home alone.Due to eu personal data protection laws, the patient information is not available from the customer.The platelet collection set 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: the lot number was not provided, therefore, a dhr and disposable history search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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 donor's physiology, lingering symptoms of prior covid infection, and/or donor's sensitivity to the procedure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS
• 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 ; 3032314970
• MDR Report Key: 11995029
• MDR Text Key: 261921532
• Report Number: 1722028-2021-00211
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female