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

Catalog Number 80300

Device Problems Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096); Decrease in Pressure (1490); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

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

Event Date 07/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is process.A follow-up will be provided.

Event Description

The customer reported approximately 11 minutes into a collection procedure they received frequent ¿draw pressure too low¿ alarms.Per the customer, the operator noticed a hematoma at the veni puncture site.The operator removed the needle and performed another veni puncture, but the alarm continued.The operator noticed a blockage in the inlet line between the access/return needle and the manifold, terminated the procedure and disconnected the donor.Per the customer, no medical intervention was required for this event.The operator applied pressure for approximately 10 minutes and allowed the donor to rest for 30 minutes.The donor left the center in stable condition.After 3 days, the center reported they followed up with the donor and the donor was fine.Donor information is not available at this time.The trima disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information and updated/corrected information.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: a definitive root cause could not be determined.Poor phlebotomy technique in association with difficult access or fragile vessels, and rapid return flows in some procedures can cause leakage of blood from the vessels into the surrounding tissue.

Event Description

The customer declined to provide the patient information.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7734969
• MDR Text Key: 115778518
• Report Number: 1722028-2018-00209
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: BK170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

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: 12/01/2019
• Device Catalogue Number: 80300
• Device Lot Number: 1712232130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/08/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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