MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLT, PLS, RBC, AUTORBC SET

Catalog Number 000000000000080360

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem Bruise/Contusion (1754)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

The customer reported that they were receiving low draw pressure alerts and had slow flow into the sample pouch toward the beginning of the platelet donation.The operator made several adjustments to the needle position, but the flow issue continued.The donation had to be stopped due to multiple alarms.Per the customer, the operator saw bruising when removing the needle and the medical staff noted clots in the needle.No medical intervention was necessary for this event.The donor is in healthy condition.Patient's full id is (b)(6) the disposable kit is not available for return because it was discarded by the customer.This report is being filed due to device malfunction in the form of operator error, that has the potential for injury.

Manufacturer Narrative

Investigation: per the customer, the operator had difficulties with venipuncture and the needle was adjusted by staff and the blood flow was slow.The needle was inspected and passed for use prior to venipuncture.A review of the lot for similar reports was carried out, none have been reported.Root cause: based on the clinical findings, the root cause for the alarm was due to clotting in the needle which resulted in the obstruction of the blood flow.Difficulty with venous access is consistent with this alarm.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and investigation.The run data file 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 (continued from initial submission): the signals in the run data file do not indicate a definitive cause for the clotted needle reported by the blood center staff.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended by displaying the non-recoverable ¿system test failure¿ alarm when there turn cycle was taking too long to empty the reservoir.It is possible that the lack of proper inlet blood flow, as indicated by the low draw pressure alarm, was due to a poor venous puncture.The clot occurred in an area that does not receive anticoagulant until the first return.It is likely the combination of the lack of anticoagulant and the lack of blood flow caused the clot to form and then prevented the reservoir from being able to empty, causing the "system test failure" alarm.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLT, PLS, RBC, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3786973
• MDR Text Key: 4431891
• Report Number: 1722028-2014-00147
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

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: 03/01/2016
• Device Catalogue Number: 000000000000080360
• Device Lot Number: 03W3203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2014
• 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 Age: 00066 YR
• Patient Weight: 73