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

Catalog Number 000000000000080449

Device Problem Pressure Problem (3012)

Patient Problem Thrombus (2101)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

The customer reported that they had multiple procedures with clotting but had no specific procedure information."at 40 minutes clock time the draw pressure was in yellow.They were unable to get the pressure up.They discontinued the procedure and noticed large clot on the end of needle".No medical intervention was required for the donor.The disposable kit was unavailable 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:- improper anticoagulation of the extra corporeal system- donor's physiology.

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.Root cause: it is likely that the observed clots at the needle occurred during troubleshooting for the access issues.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.A review of related clotting issues for this customer does not indicate that the clots or access issues were related to the acda as initially suggested by the customer.This customer has a higher frequency of access issues than average, regardless of the acda used.The cause for the reported clots is the result of customer phlebotomy and access issue management.Additional information: follow up with the customer by email from terumo bct's field performance team, instructed the customer to focus on managing access issues.

Manufacturer Narrative

The run data file (rdf) was analyzed for this event.Signals in the run data files show numerous access issues, however the run data files did not indicate a conclusive cause for the possible reported clotting.No unusual process variable was identified in the run data files and the trima accel systems operated as intended.There also does not appear to be a conclusive connection between the acda manufacturer and the procedures with reported needle clots.Though not conclusive, it may be possible the needle clotting may be related to higher than average procedures with access issues.

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: 4633731
• MDR Text Key: 5571977
• Report Number: 1722028-2015-00108
• 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: 10/01/2015
• Device Catalogue Number: 000000000000080449
• Device Lot Number: 10V1203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/15/2015; 05/07/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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: 00020 YR
• Patient Weight: 65