MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLASMA,RBC TLR FILT

Catalog Number 000000000000080483

Device Problems Reflux within Device (1522); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

The customer reported that during a procedure, the operator heard an 'air' sound from the disposable set and observed a small portion of blood going back to the donor.No trima alarms occurred and the operator was able to continue the procedure.Due to eu personal data protection laws, the patient identifier and age are not available from the customer.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: per the customer, when opening the white clamp of the donor line in order to collect the first blood volume, the second white clamp and the blue clamp were still closed on the disposable set.The run data file was analyzed for this event.The run data file analysis did not show a root cause for why the air sound was heard.During the loading of the cassette, a ¿pressure test failure¿occurred, which could mean that either of the white clamps was left open or the cassette was not loaded properly.Based on the event description, if the sample bag clamp and the blue clamp were closed when the donor line clamp was opened, the system was closed and air could not get into or out of this area.It is also possible that the needleless access port may have had a small floor pressurized air to escape, as it is between the donor line clamp and the other clamps.However, this is highly unlikely since the procedure was able to complete successfully and there were no other issues found during the run.The small portion of blood that was seen moving back to the donor may have been solely from the clamp opening.When the clamps are opened, the fluid in the lines will move slightly to equalize to the open clamp pressure.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out, none have been reported.Root cause: the disposable set was unavailable for specific root cause analysis.Per the rdf analysis, it is possible that operator error in leaving clamps open, or misloading the disposable cassette could have caused the air sound experienced by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLASMA,RBC TLR FILT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3745398
• MDR Text Key: 4223478
• Report Number: 1722028-2014-00118
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK120049
• 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
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Catalogue Number: 000000000000080483
• Device Lot Number: 01W2123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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: 50