MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC, AUTO PAS S

Catalog Number 80420

Device Problems Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Sweating (2444)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: during customer follow-up, the customer stated that this event occurred dueto a new operator at the customer's site.The operator noticed that the disposable set wasalready loaded on the trima machine.Per the customer, the operator did not follow the promptsproperly on the trima machine.The operator connected the donor during purge cycle of startupand did not connect the anticoagulant.When the operator noticed blood in the disposable set,the operator stopped the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure, the donor complained of precordial pain, dyspnea, sweating and developed pallid face.Per physician's order, an ambulance was requested.As the ambulance arrived approximately 40 minutes after the request, the donor was asymptomatic.The ambulance physician examined the donor and ordered an electrocardiogram and gluometry.Tests results were within normal range.The final diagnosis of the donor was determined to be a headache.On the following day (04/05/2017), the donor visited the customer's site for follow-up due to chest pains.Per physician's order, the donor was examined and monitored.The customer declined to provide patient (donor) identifier and weight.The 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: 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.Based on the available information from the complaint description, it was reported that anticoagulant was not connected, however, the donor was connected in a stage where a donor should not have been and blood was noted to be in the tubing set.The operator did not reach the stage of the procedure where anticoagulant should be added.Signals from the rdf indicate the donor was likely connected before the tubing set was lowered onto the machine.If the donor needle line clamps were open at this time, blood would have freely entered the tubing set.It is unknown how long the donor may have been connected before the tubing set was lowered onto the machine.Rdf analysis showed the operator likely closed the clamp to the needle line prior to the system check for this clamp closure.With an unknown amount of blood without anticoagulant in the system, the tubing set test was unable to pass and the operator eventually unloaded the tubing set and turned off the machine.Return of blood through donor rinseback is not an option during the tubing set test as the donor should not be connected at that point.Investigation is in process.A follow-up report will be provided.

Event Description

Donor's weight was obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information in investigation is in process.A follow-up report will be provided.

Event Description

On the following day (b)(6) 2017), the donor visited the customer's site for follow-up due tochest pains.Per physician's order, the donor was examined and monitored.No issues were found with the patient/donor.

Manufacturer Narrative

This report is being filed to provide additional information.(b)(4).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.There was additional risk identified of possible air to donor due to the operator error where the donor was connected at a stage in the procedure when he shouldn't have been connected.This possible air to donor was thought to possibly have contributed to the donor reported symptoms.Injection of air into the venous system carries with it health risks dependent on the volume and rate of injection normalized to subject size (weight), the position of the subject and the health status of the subject.Per terumo bct's internal risk evaluation documentation, the trima device is designed to prevent air embolism by removing air from the tubing set prior to connecting the donor to the device.Instructions for use in the operators manual and on-screen clearly state the appropriate sequence of steps in operating the trima accel, but these were not followed by the operator.The operator was not appropriately trained to conduct procedures on the trima accel and connected the donor prematurely.The donor received a medical evaluation after experiencing symptoms that could indicate a possible air embolism.Results were unremarkable, but an air embolism cannot be excluded based on the work-up performed.The trima accel device, which included the arm system, functioned correctly by not permitting initiation of the run due to tubing pressure test failures.The donor did not experience a serious injury and no continuing symptoms or sequelae have been reported by the donor.The donor's symptoms suggest a possible air embolism, but the information available from the customer site, the diagnostic testing, and the rdf for the procedure neither confirm nor rule out a donor air embolism.Root cause: 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.The root cause for the reported possible air to donor was operator error as indicated from the information provided from the complaint description and run data file analysis.Based on the available information from the complaint description, it was reported that anticoagulant was not connected, but the donor was connected to the system before permitted by the system.It is unknown how long the donor may have been connected before the tubing set was lowered onto the machine.Run data file analysis showed the operator likely closed the clamp to the needle line prior to the system check for this clamp closure as this check passed within the expected ranges after the tubing set was lowered.With an unknown amount of blood without anticoagulant in the system, the tubing set test was unable to pass and the operator received 5 ¿pressure test error¿ alerts during the tubing set test.The operator then turned off the machine.Return of blood through donor rinseback is not an option during the tubing set test.There is no evidence from the incident description or the run data file that air was returned to the donor.The run data analysis indicated that the equipment performed as intended by not permitting initiation of the run due to multiple pressure test errors.The run data analysis indicated that the equipment performed as intended by not permitting initiation of the run due to multiple pressure test errors.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: terumo bct customer support contacted the customer's site to determine if the facility wanted re-training regarding the reported incident.The operators were retrained in april 2017.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC, AUTO PAS S
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6528664
• MDR Text Key: 73897844
• Report Number: 1722028-2017-00159
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2017

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 Expiration Date: 12/01/2018
• Device Catalogue Number: 80420
• Device Lot Number: 12Z1312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; 07/20/2017; 09/26/2017; 11/13/2017
• Supplement Dates FDA Received: 05/17/2017; 07/25/2017; 09/29/2017; 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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; Required Intervention
• Patient Age: 00032 YR
• Patient Weight: 78