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

Catalog Number 000000000000080449

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The customer reported that there were draw pressure alarms and procedure was discontinued prior to the platelet valve opening.The customer stated after the procedure was discontinued clotting was noted in the needle, the lines and the centrifuge.No medical intervention was required for the donor and no follow-up was necessary.The disposable kit is not available for investigation because the customer discarded it.

Manufacturer Narrative

Root cause: this disposable set was unavailable for specific root cause analysis.Possible root causes include but are not limited to:- donor's physiology- improper anticoagulation of the extra corporeal system.

Manufacturer Narrative

Root cause: the cause for the reported clots is the results of customer phlebotomy and access issue management.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable set was unavailable for specific root cause analysis.A review of related clotting issues for this customer does not show an indication that the clots or access issues were related to the acda as initially suggested by the customer.It is more likely that the reported clots were the result of access issue management.This customer has a higher frequency of access issues than average.It is possible that the observed clots at the needle occurred during troubleshooting for the access issues and the clots were not the cause for the access issues.The increase in incomplete procedures due to draw and return issues could have contributed to the perceived increase in clotting issues.No unusual process variable was identified in the run data files and the trima accel systems operated as intended.Additional information: follow-up with the customer was completed for the customer to focus on managing access issue.

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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4633470
• MDR Text Key: 5612170
• Report Number: 1722028-2015-00106
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2015

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: 09/01/2015
• Device Catalogue Number: 000000000000080449
• Device Lot Number: 09V1127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/15/2015; 05/08/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00028 YR
• Patient Weight: 106