MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, SAMPLER, AUTOPAS, MLTPLASMA SET

Catalog Number 000000000000080310

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

The customer reported that they experienced a leak on 2 disposable sets.The blood leak was found inside the centrifuge.They did not receive an alarm.No medical intervention was necessary.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: two trima accel sets were received for investigation.Each kit was leak tested and a leak was found at the control y connector of each set.Specifically, the leak source was at the knit line of the rbc port of the control y.The customer also sent photographic evidence of the blood spray confirming the source of the leak.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the leak in the control y parts is due to a leak path at the knit line and is located on the first shoulder of the control y near the rbc port.The knit line is created as a normal part of the molding process.In this case, the injection process was shut off prematurely and the material did not completely fill along the knit line and a void or gap resulted.During centrifugate the control y is subject to high internal pressure and an opening can form along the knit line which can allow for a leak path.This type of leak is a very fine spray which may not signal the centrifuge's leak detector to alarm.Corrective action: the root cause has been identified and an immediate corrective action has been implemented at the supplier.The corrective action is to increase the maximum time allowed for filling of the mold to ensure an adequate resin injection time.This allows for a complete knit line of the part.

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 PLATELET, SAMPLER, AUTOPAS, MLTPLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4200514
• MDR Text Key: 20776250
• Report Number: 1722028-2014-00428
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

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: 07/01/2016
• Device Catalogue Number: 000000000000080310
• Device Lot Number: 07W1201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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