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

Catalog Number 80410

Device Problems Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 03/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that approximately 11 minutes before the end of a collection procedure, they received multiple 'flow' alarms.While the operator disconnected and withdrawn the needle from the donor's arm, a clot was observed in the needle.It is unknown at this time if medical intervention was required for this event.Patient (donor) information and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

The customer declined to provide patient identifier and outcome.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) 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: the rdf confirmed this procedure was terminated early due to persistent access pressure alerts.Rdf analysis did not show a conclusive root cause for the coagulation found at the access needle site at removal.Analysis did not show signs of clotting occurring within the tubing set.The platelet product collected at a steady state expected concentration.If clots enter the tubing set, there are filters to ensure they are not returned to the donor.Based on the access alerts early in the procedure, it is possible the venipuncture activated the clotting factors in the blood at the needle site.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC, AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6504093
• MDR Text Key: 73456962
• Report Number: 1722028-2017-00149
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2017

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: 11/01/2018
• Device Catalogue Number: 80410
• Device Lot Number: 11Z1121
• Other Device ID Number: 05020583804104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: 07/18/2017; 08/21/2017
• Supplement Dates FDA Received: 07/28/2017; 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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: 00027 YR
• Patient Weight: 87