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

Catalog Number 80337

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during set up for a donation, they received a 'pressure test error alarm.They found that the pinch clamp on the diversion bag line tubing was not properly closed, and there was air in the diversion bag.The customer was able to remove the air from the diversion bag and continue the procedure.Patient (donor) information and outcome is not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Root cause: signals in the rdf showed ¿pressure test error¿ alerts in this procedure occurred when the system was verifying that the sample bag clamp was closed.If the system does not pass this test twice, then the operator is prompted to end the procedure because the system is unable to achieve the required pressure.Based on the customer's report, the sample bag clamp was not fully closed and was not fully occluding the line during the tubing set test,therefore generating the two ¿pressure test error¿ alerts.Correction: a voluntary medical device product recall was released by terumo bct on september 15, 2014 to communicate more information about the "air in the sample bag safety alert".Corrective and preventive action: an internal capa has been initiated to address air in the sample bag incidents.

Manufacturer Narrative

This report is being filed to provide additional information.Terumo bct's sales representative followed-up with customer and explained the possible failure modes and the necessary actions to be performed by the customer if air is in the bag, and risks to the donor.

Event Description

No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5290577
• MDR Text Key: 33895085
• Report Number: 1722028-2015-00650
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK150269
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 80337
• Device Lot Number: 09Y0105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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