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

Catalog Number 80440

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infiltration into Tissue (1931)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer indicated that they were not able to search for the donation record due to the age of the incident.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer also indicated that the incident occurred over 9 years ago and the disposable set was not available for return, and the procedural details were unavailable.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- phlebotomist inadvertently sticking the needle through the distal side of the vein.- abrading the needle entry site.- abrading the vein wall due to needle movement during the procedure.- an excessive high intravenous pressure by having a higher flow rate than could be accommodated by the cannulated vein.Per terumo bct's internal medical review, insufficient information is provided to determine whether the trima system caused or contributed to the donor¿s infiltration event.

Event Description

During a discussion between a terumo bct representative and a (b)(6) employee, it was brought up that an infiltration had occurred back in 2009 with a female donor.There was no mention of any medical intervention that took place, but the customer was sure that the facility completed an in-house injury report and followed up with the donor.Donor information and outcome are not available as the organization had recently changed their software and was unable to search for the donor's donation record.Due to the time that has passed, the trima disposable set is not available for evaluation because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

Per the customer, no medical intervention occurred as a result of this incident.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET SAMPLER, 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: 7876895
• MDR Text Key: 120282641
• Report Number: 1722028-2018-00253
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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