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

Catalog Number 80337

Device Problems Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the collection set was returned for investigation.No issues were found with the set.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during setup for a collection procedure, they received a 'pressure test error' alarm and noted air in the sample bag.The operator stopped the procedure and unloaded the set prior to connecting a donor.No donor was connected at the time of the event, therefore, no patient (donor) information is reasonably known.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

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: review of the rdf confirmed that during the initial loading of the kit, an alarm was generated during the disposables test due to access decay failure.Based on the event description of ¿air observed in the diversion bag line tubing¿, it is likely that the sample bag clamp was not occluding the tubing properly and air entered the sample bag during the disposable test.As the system was unable to maintain the necessary pressure, the alarm was generated.The operator unloaded the cassette and removed the kit to return to terumo bct for evaluation.There were no anomalies found with the returned kit upon inspection of the returned kit.Root cause was determined to be partial occlusion of the sample bag line clamp.Possible causes for this include, but are not limited to, a misassembly of the tubing within the clamp or a clamping advertently being left open.Corrective action: an internal capa has been initiated to evaluate reports of air in samplebag.

• 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: 5939227
• MDR Text Key: 54765310
• Report Number: 1722028-2016-00508
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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
• Report Date: 09/09/2016

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: 06/01/2018
• Device Catalogue Number: 80337
• Device Lot Number: 06Z0304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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