MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET + SAMPLER, AUTOPAS, MLT PLS SET

Catalog Number 000000000000080310

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

The customer reported that after venipuncture for a collection procedure, the operator noticed clotting in the needle.While the operator disconnected and removed the needle from the donor's arm, they noted a clot approximately 4cm in length removed with the needle.No medical intervention was required for this event.Due to eu personal data protection laws, the patient information is not available from the customer.Patient outcome is unavailable at this time.Terumo bct is awaiting return of the disposable set for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection the following observation was made: the set had gone through prime and started to draw blood from the donor/patient.Blood was present up to the inlet manifold.Some clotting was noticed in the first half of donor line.Further inspection of the donor line confirmed the presence of numerous blood clots.The disposable was assembled correctly.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 definitive root cause could not be determined.Possible causes include butare not limited to: donor access problem - kinked or clamped draw line - inadequate ac ratio or flow.

Manufacturer Narrative

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, MLT PLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4958074
• MDR Text Key: 6253955
• Report Number: 1722028-2015-00471
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 07/07/2015

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: 04/01/2017
• Device Catalogue Number: 000000000000080310
• Device Lot Number: 04Y1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2015
• 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