MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, SAMPLER, PLS, RBC, AUTOPAS SET

Catalog Number 000000000000080420

Device Problem Improper Flow or Infusion (2954)

Patient Problem Chemical Exposure (2570)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

No medical intervention was required for this event.

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.The abnormality that was noted in the cassette access pressure sensor (aps) was that the retaining ring showed signs of plastic deformation.No other abnormalities were noted.The run data file (rdf) was analyzed for this event.During the disposable test, a ¿pressure tester¿ alarm was generated.The cassette was unloaded and reloaded; however, the same alarm was generated at the same point in the disposable test.Since two of the same alarms were generated, an ¿air removal failure¿ alarm was generated and the run had to be ended.Root cause: the aps assembly cassette retainer ring was deformed in a manner that prevented the sensor from functioning correctly.As a result, the system access pressure ready was negatively affected.The ¿pressure test error¿ alarm was generated when the system was verifying that the sample bag was closed.It is possible that the white clamps on the donor line were not closed or fully occluding the lines or the cassette was not loaded correctly.

Manufacturer Narrative

Investigation: per the customer, the disposable set was setup on one machine and received a 'pressure test' alarm.They then was loaded and setup the disposable set on another machine,which is where the incident occurred.The disposable set was returned for investigation.The set was visually inspected and appeared ok.Ac was present to manifold.The sample bag had been removed and was not returned, some blood was noted in the y connector adjacent to the needle.An abnormality was noted in the cassette aps.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after the pressure test for a collection procedure, the donor was connected to the machine.After sampling, the operator saw what appeared to be the anticoagulant (ac) flowing directly to the donor.The operator immediately closed the clamp and aborted the procedure.Due to eu personal data protection laws, the patient information is not available from the customer.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

Corrective/preventive action: a possible risk of air embolism was identified related to this failure.An internal capa request has been initiated to address this issue.

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 appropriately.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, SAMPLER, PLS, RBC, AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3942433
• MDR Text Key: 16304020
• Report Number: 1722028-2014-00273
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: BK120049
• 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,Followup,Followup
• Report Date: 06/20/2014

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: 01/01/2015
• Device Catalogue Number: 000000000000080420
• Device Lot Number: 01V1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/07/2014; 11/14/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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