MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER, AUTO PAS, MLTPLS SET

Catalog Number 82310

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation : the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.The platelet collection 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: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.The trima deviceoperated as intended by flagging the procedure to verify wbcs.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

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.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.Root cause: the trima accel automated blood collection system operated as intended by flagging the platelet product while the mss duration exceeded 30 minutes measured from the donor disconnect time to the mss disconnect time.Once the mss duration exceeds 30 minutes, the blood residuals left in the cassette can 'dry' and not be removed properly during prime which potentially can lead to wbc contamination.As the trima accel automated blood collection system flags at the end of the pas addition, it is unknown at this time in the delay of adding the pas solution, however, the delay caused the flags reported by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

Manufacturer Narrative

Additional investigation: terumo bct followed up with the customer.The customer was made aware of the event and provided with a retraining on the appropriate procedures.Updated root cause: review of the run data file showed that the ¿channel line clamp error¿ message was generated as the platelet additive solution addition was ended more than 30 minutes after the donor was disconnected.In this procedure, the platelet additive solution (pas) prime phase started 24 minutes after the donor was disconnected and the pas addition ended 31.29 minutes after the donor was disconnected.The trima accel device will sound an audible alert every 10 minutes to remind the operator that platelet additive solution is not yet added.Review of the run data file showed that the ¿channel line clamp error¿ message was shown as the pas addition was ended more than 30 minutes after the donor was disconnected.In this procedure, the pas prime phase started 10 minutes after the donor was disconnected and the platelet additive solution addition ended 30.4 minutes after the donor was disconnected.The trima accel device will sound an audible alert every 10 minutes to remind the operator that pas is not yet added.The trima accel automated blood collection system will flag the platelet product when the mss duration exceeds 30 minutes, measured from the donor disconnect time to the mss disconnect time.This is because, over time, blood residuals left in the cassette can ¿dry¿ and not be removed properly during prime.This can lead to product contamination.There is no alarm ¿ just the flag at the end of the pas addition.Based on the dlog analysis, the customer¿s delay in adding the pas was the cause of the reported alarm, "verify wbcs in platelet product." there is no evidence or suspicion of device malfunction based on the rdf analysis.

Event Description

The customer declined to provide wbc count for this event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER, AUTO PAS, MLTPLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7154169
• MDR Text Key: 96232683
• Report Number: 1722028-2017-00525
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK170059
• 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: 12/29/2017

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: 07/01/2019
• Device Catalogue Number: 82310
• Device Lot Number: 1707251130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/23/2018; 02/13/2018; 04/04/2018; 05/24/2018
• Supplement Dates FDA Received: 01/25/2018; 02/16/2018; 04/06/2018; 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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