MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET AUTOPAS PLASMA RBC SET

Catalog Number 82420

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used trima disposable with acda attached was received for investigation.Upon receipt of the disposable it was noted that the access needle and diversion bag, plasma bag and collect bags had been rf sealed and removed prior to return of the disposable.Blood product could be observed to be interspersed throughout the inlet coil,cassette and return reservoir.The donor line had been rf sealed and the donor line pinch clamp was noted to be in the open position.The sample line pinch clamp was observed to be closed.The ac bag appeared to be full and examination confirmed that the frangible had been fully broken.Ac could be observed within the drip chamber and throughout the ac pump header and inlet coil.The disposable was examined for any kinks,occlusions, missing parts or other misassembly and none were found.The run data file was analyzed for this event.Review of the run data file showed the ¿ac prime failure¿ alarm was generated during ac priming of the return line.This alarm was generated because the pressure reading at the aps sensor was not below a negative pressure limit after the appropriate volume pumped by the return pump.More specifically, signals showed the aps reading unexpectedly increased during ac prime, indicating a clamp was opened and/or donor was connected early.During the ac priming sequence, the system expects the pumps to be pulling against closed needle and sample bag line clamps.This will lead to a negative pressure reading at the aps sensor.If the donor is connected and the needle line is unclamped during the ac priming sequence, the pumps will pull blood from the donor, leading to a positive pressure reading.If blood is entering during the ac priming sequence, coagulation in the tubing set is unknown and therefore the procedure must be terminated.Analysis of the run data file showed that the donor information was never entered and the start draw button was never reached.Based on the available information, it is confirmed that the donor has been connected to the device during ac prime.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a donation procedure on the trima accel, the device gavean alarm 109 (anticoagulant (ac) prime failure) immediately after start-up: failure of pre-filling the ac line.Perthe customer, the set was installed correctly.The ac break pin was broken but was correctly fixed in the ac lines lot.The customer also reported the donor was connected to the device during the alarm, but no injury occurred and medical intervention was not required.Patient identification and age are unavailable at this time.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.Root cause: review of the run data file showed the ¿ac prime failure¿ alarm was generated during ac priming of the return line.This alarm was generated because the pressure reading at the aps sensor was not below a negative pressure limit after the appropriate volume pumped by the return pump.More specifically, signals showed the aps reading unexpectedly increased during ac prime, indicating a clamp was opened and/or donor was connected early.During the ac priming sequence, the system expects the pumps to be pulling against closed needle and sample bag line clamps.This will lead to a negative pressure reading at the aps sensor.If the donor is connected and the needle line is unclamped during the ac priming sequence, the pumps will pull blood from the donor, leading to a positive pressure reading.If blood is entering during the ac priming sequence, coagulation in the tubing set is unknown and therefore the procedure must be terminated.Analysis of the run data file showed that the donor information was never entered and the start draw button was never reached.Based on the available information, it is confirmed that the donor has been connected to the device during ac prime.Based on the evaluation of the returned disposable set and analysis of the run data file, the root cause was due to premature connection of the donor.Correction: several attempts were made to contact the customer to offer retraining.The customer did not respond to the request.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in-process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient identifier and age are not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET AUTOPAS PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7838937
• MDR Text Key: 119653240
• Report Number: 1722028-2018-00237
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 08/31/2018

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: 05/01/2020
• Device Catalogue Number: 82420
• Device Lot Number: 1805241230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/24/2018; 10/21/2018
• Supplement Dates FDA Received: 10/19/2018; 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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 Weight: 102