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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, AUTO PAS, PLASMA SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, AUTO PAS, PLASMA SET Back to Search Results
Catalog Number 82321
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation: a used trima accel set was returned to terumo bct for investigation.Visual inspection confirmed the presence of blood throughout the inlet line, cassette, channel and return reservoir.The set was inspected for kinks, occlusions, misassemblies and leaks - none were identified.The run data file (rdf) was analyzed for this event.During the tubing set test, the system performs a pressure test to verify the integrity of the tubing set, the pump function, and the pressure limits of the access and return pressure sensor.Review of the run data file during the tubing set test indicate that the return pump could move un-hindered.The return pump speed was as expected, and the aps readings were appropriate for the tubing set test to pass successfully.At the moment of donor connection, the aps reading was negative, as designed,and therefore no air was returned to the donor when the donor was connected.A terumo bct service technician checked out the device at the customer site and performed a full system checkout including a functional verification and successful auto test.The machine was found to be within manufacturer's specifications.Photographs were reviewed with the customer that showed that the tubing of the air vent/collection bag had become wrapped around the return rotor.Investigation is in process.A follow up report will be provided.
 
Event Description
The customer reported that a donor was potentially exposed to an air embolism during a platelet/plasma donation on a trima device, the customer was concerned for donor's health.The customer reported that the air started in the vent bag, then due to incorrect loading by the operator, when the machine started the vent bag line became trapped behind the pump causing an occlusion.The only place for air to go was through needle.The customer stated that there were no alarms to alert the staff to the error.The air in donor line was noticed by staff at start of procedure and the needle was immediately removed.Per the customer, the donor was placed in the trendelenburg position (head down and lay on left side) and (b)(6) (emergency services) was called.The paramedics attended within minutes and took the donor to a&e by ambulance.Per the customer the donor was discharged the same day.Due to eu personal data protection laws, further patient information is not available from 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 investigation: it was confirmed in follow-up that the customer understood that this issue wascaused by operator error.A review of the device history record (dhr) for this unit showed no irregularities duringmanufacturing that were relevant to this issue.Inevstigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provided in investigation: photographs were submitted to terumo bct by the customer in addition to thedisposable tubing set.Photographs show that the tubing of the air vent/collection bag hadbecome wrapped around the return rotor.Additionally, it appears that the return pump headertubing was not fully seated and may have been kinked off.Updated investigation: the run data file (rdf) was anaylzed for this event.During thetubing set test, the system performs a pressure test to verify the integrity of the tubing set, thepump function, and the pressure limits of the access and return pressure sensor.Review of therun data file during the tubing set test indicate that the return pump speed was as expected, andthe aps readings were appropriate for the tubing set test to pass successfully.At the moment ofdonor connection, the aps reading was negative, as designed, and therefore no air was returnedto the donor when the donor was connected.Since the donor was only connected for approximately 1 minute, and only when the pumps werepulling fluid into the set, there was no return or rinseback.The rdf showed that blood priming ofthe inlet line and 40 seconds of blood priming of the return line occurred before the operatorchose to discontinue the procedure.The access pressure sensor (aps) reading was shown toincrease when the return pump was trying to pull blood into the return line.This signal indicates itis likely that the clamp on the donor access line was closed at the beginning of blood priming ofthe return line while the ac pump was still running.Shortly after, the operator chose to terminatethe procedure.There were no alarms that caused the procedure to stop.The closed donoraccess line clamp also confirms why the returned set does not show much blood in the return linefor the 40 second blood priming of the return line that occurred.Analysis of the rdf is unable to tell when the air vent/collection bag and return pump headertubing became kinked in the return pump raceway.Investigation is in process.A follow-up report will be provided.
 
Event Description
Patient's age,gender and weight information were obtained from the run data file (rdf).
 
Manufacturer Narrative
This report is being filed to provide in correction: the customer was able to identify their loading error and performed refreshertraining to the staff.Reviewed the relevent stages from the trima operators manual (review ofloading guide).No further training was required.Investigation is in process.A follow up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide addtional information in b.5.Investigation is in process, a follow-up report will be provided.
 
Event Description
Per customer follow-up, the donor was taken to a&e on the day of the event, but did notrequire any treatment, he was sent home after a short period of observation as a precautionarymeasure.The donor has fully recovered and has made a successful platelet donation since theevent.
 
Manufacturer Narrative
This report is being filed to provide in investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The patient was transported to the a&e and only observed, no medical intervention was required for this event and there was no risk of air being returned to the donor per rdf analysis.Correction: the customer was able to identify their loading error and performed refresher training to the staff and eviewed the relevant stages from the trima operators manual (review of loading guide).No further training was required.Root cause: based on the photo provided by the customer and the results of the part evaluation, the root cause was attributed to a set loading error by the operator.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS PLATELET, AUTO PAS, PLASMA SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
MDR Report Key8723273
MDR Text Key148820175
Report Number1722028-2019-00152
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/21/2019
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 Date02/01/2021
Device Catalogue Number82321
Device Lot Number1902152230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/21/2019
Supplement Dates Manufacturer Received06/24/2019
08/28/2019
09/10/2019
09/24/2019
11/25/2019
Supplement Dates FDA Received07/16/2019
08/30/2019
09/24/2019
10/18/2019
12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age00029 YR
Patient Weight115
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