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

Catalog Number 80300

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Analysis of the rdf showed that platelets did not exit the lrs chamber as expected.Instead, platelets were shown to be delayed in exiting and did not maintain a steady state concentration.The platelet concentration exiting the lrs chamber was also shown to be slightly erratic.Although these signals are imperfect, they do not conclusively show that clumping was occurring outside of the product bag.Signals from the level sensors show the reservoir was filling and emptying as expected, indicating no large clots were located in the reservoir.Based on these signals in the rdf analysis, it cannot be confirmed that saline was connected instead of ac.Investigation is in process.A follow-up report will be provided.

Event Description

The distributor would like the run data file investigated to determine if the rn had connected saline instead of anticoagulant (acd-a) for a collection procedure.The distributor stated that they were informed by the customer of an operator mishandling incident.Approximately 52 minutes into a collection procedure, the rn discovered that she inadvertently connected saline instead of anticoagulant (acd-a) and they noticed clumping in the platelet bag.Per the medical officer, the patient (donor) was contacted.The donor stated that he was ¿fine¿.Patient (donor) identifier and age are not available at this time.Patient (donor) gender and weight were obtained from the run data file (rdf).The trima 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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Root cause: analysis of the run data file showed that platelets did not exit the lrs chamber as expected.Instead, platelets were shown to be delayed in exiting and did not maintain a steady state concentration.The platelet concentration exiting the lrs chamber was also shown to be slightly erratic.Although these signals are imperfect, they do not conclusively show that clumping was occurring outside of the product bag.Signals from the level sensors show the reservoir was filling and emptying as expected, indicating no large clots were located in the reservoir.Based on these signals in the run data file, analysis cannot confirm that saline was connected instead of ac.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6977401
• MDR Text Key: 91094463
• Report Number: 1722028-2017-00415
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: BK160116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2017

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: 02/01/2019
• Device Catalogue Number: 80300
• Device Lot Number: 1702172131
• Other Device ID Number: 05020583803008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 05/23/2018
• Supplement Dates FDA Received: 11/17/2017; 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• 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
• Patient Weight: 83