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

Catalog Number 80440

Device Problems Use of Device Problem (1670); Gas/Air Leak (2946)

Patient Problems Dyspnea (1816); Discomfort (2330); Reaction (2414)

Event Date 06/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: during follow-up, the customer confirmed the sample pouch did fill with air during tubing set test and the customer could not say for certain the donor received air from the pouch.The initial flash of blood from the phlebotomy disappeared when the clamp was opened.A terumo bct service technician checked out the machine at the customer site and a full functional check out was performed.An autotest and saline run were successfully completed and there where no abnormalities found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that air was delivered to the donor during a platelet collection procedure on a trima device.The operator loaded and primed the machine and performed the venipuncture.A flash of blood was visualized in the needle tubing.The operator opened the white clamps to fill the sample pouch and noticed air in the sample pouch.The donor reported feeling a bubbling sensation in his air and discomfort in his arm as well.The operator removed the needle from the donor and never started the draw.The donor began to cough and reported shortness of breath.An emergency medical team (emt) was called and the donor was transported to the hospital with a potential of an air embolism per orders from the medical director.During follow-up, the customer reported that the donor recovered and it was determined to be a reaction to the iodine.Full patient id: (b)(6) nterumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Root cause: based on the part evaluation and the rdf analysis, the root cause was determined to be a user interface error.Improper closure of the white pinch clamp resulting in improper occlusion of the tubing which allowed air to enter the sample bag.Corrected corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.

Manufacturer Narrative

This report is being filed to provide additional information.No retraining was provided specific to this event as customer failed to respond to proposed training request.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: a used trima disposable set containing blood was returned for investigation.Itwas noted that the set was returned with a full bag of ac attached.Additionally, blood had notcirculated past the sample bag or 2-1 y connection on the access assembly.Visual inspectionrevealed that the sample bag was full of air.The two white and one blue pinch clamps above the3-1 manifold were all closed.Prime fluid had circulated throughout the set.A review of the device history record (dhr) for this unit showed no irregularities duringmanufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The determination of the reaction to be related to the iodine was the report of the customerand not the determination of terumo bct.After multiple follow-up attempts, the customer hasnot provided any further procedural details surrounding this event of the patient.

Manufacturer Narrative

This report is being filed to provide in investigation: the run data file (rdf) was evaluated to aid in the investigation anddetermine which alarms were generated during the procedure.The ¿pressure test error¿ alertwas generated during the tubing set test in this procedure because the expected pressureincrease was not seen in the allotted volume pumped.Based on the analysis of the run datafile, it is suspected that the pressure increase was not sufficient because the pinch clamp onthe sample bag line was likely not occluding the line properly.If the clamp on the sample bagline is not occluding the line properly during the tubing set test, air can have a pathway toenter the sample bag.As evidenced by the alarms noted in the run data file analysis, thesystem alarmed appropriately in this instance.The operator pressed ¿continue¿ roughly 40seconds after the alert initiated and the disposable test continued and completed without anyadditional alerts.The run data file does not provide insight into whether the operator followedthe alert instruction and expressed the air in the sample bag following the alert.After the disposable test, the donor information was entered, and the procedure selected.After reaching the connect donor screen, the ¿continue¿ button was never pressed (procedurenever started).Power to the device was turned off roughly 4 and a half hours after themachine was on the donor connect screen.While on the donor connect screen, there is aslight increase in aps pressure ~20-30 mmhg from what was recorded during the pressuretest, but it does not reach 0 mmhg or ever measure positive pressure.It cannot bedetermined from the run data file specifically what time the donor would have been connectedto the machine, nor any other behavior from the operator end because the blue donor lineclamp appeared to have been closed as prompted, and therefore provides no insight into thepressures at the donor access site.Updated investigation: a used trima set containing blood was returned to terumo bctfor investigation.It was noted the set was returned with a full bag of acd-a attached.Additionally, blood had not circulated past the sample bag or 2-1 y connection on the accessassembly, indicating that the operator had connected the donor to divert the donor's bloodinto the blood diversion bag.Visual inspection revealed the blood diversion bag was fully inflated with air.The sidewall clampon the blood diversion bag line, the pinch clamp on the inlet line, and the blue pinch clampbetween the 2 to 1 and 3 to 1 manifold were all in the closed position.The blood diversion bag tubing was closed slightly off center.The sidewall clamp was openedand damage was observed on the anvil and the sidewall.Terumo bct engineer was able toreplicate the failure by closing the clamp with the tubing slightly off center.A slight resistancewas met while attempting to close the clamp.However, it was possible to close the clampwhen extra force was applied to the clamp.This created a triangular pathway on the sidewallwhich allowed pressurized air to get through, and continually to fill the sample bag during thedisposable pressure tests.Correction: an internal capa was created to address the trima sidewall pinch clamps.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10 and updated information in g.1and g.2.Investigation: per the customer, the operator saw blood in the inlet line after performing thevenipuncture, and the blood went back to the donor after the clamp on the inflated blooddiversion bag was opened.The droplets of blood in the tubing found during the set investigationconfirmed the customer's statement.Corrective action: an internal capa has been initiated to reduce the occurrence of air in thesample bag.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8817177
• MDR Text Key: 152026164
• Report Number: 1722028-2019-00194
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 80440
• Device Lot Number: 1904104251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00027 YR
• Patient Weight: 100