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

Catalog Number 000000000000080300

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 11/01/2013

Event Type  malfunction  

Event Description

The customer reported that 10 minutes into the procedure, the operator noticed a clump in the needle and had to end the procedure.The patient information is unavailable at this time.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

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 was investigated for the machine and date of the reported incident.The file did not show a concern resembling that of the customer's complaint.Attempts to confirm the machine serial number and date of the procedure were unsuccessful as the operator could not remember those details.It is not with complete certainty that the correct file was used for analysis but is the best attempt based on the initial, customer supplied information.Root cause: a definitive cause for the clot in the needle could not be determined.Possible reasons for this to occur early in the procedure as indicated by the customer are, but not limited to, poor venous puncture which doesn't allow the skin plug to transfer to the sample pouch, inadequate ac ratio, and incorrect solution attached.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf showed that platelets exited the chamber shortly after the platelet valve opened.The collection proceeded without incident.There were no access pressure alarms generated or flow adjustments made during the run.There were no indications of issues with the donor access as reported in the complaint.It is not clear why the operator ended the run after the ¿low concentration¿ alarm.This alert was generated as platelets were not exiting as expected and would be unrelated to donor access issues.As donor rinseback was successfully performed at the end of the run, it is not suspected that there were issues with the donor access.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation evaluation and corrective actions are in process.A follow-up report will be provided.

Event Description

The customer declined to provide the patient information.No medical intervention was necessary for this event.The operator let the donor have a rest and provided the donor with some water after the procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3550214
• MDR Text Key: 4211501
• Report Number: 1722028-2014-00002
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: BK120017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 06V2107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2013
• 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