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

Catalog Number 82321

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/15/2017

Event Type  malfunction  

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

Event Description

Customer stated that during a platelet and plasma donation air bubbles were noticed heading back to the donor during a return phase.The donation was stopped immediately and a clamp was applied.Donor left the donation site with advice from the customer.Full patient (donor) id: (b)(6).Age, gender and weight are not available at this time.The platelet/plasma collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the air in the return line is undetermined.Signals in the rdf showed that the collection proceeded as expected with no alerts or unusual events, and the rdf analysis did not identify any signals from the level or pressure sensors that would indicate there was air in the disposable set.Possible causes include, but are not limited to: manufacturing defect that resulted in air being pulled into the tubing set past the last point of detection - poor venipuncture resulting in air being drawn into the set.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Donor's gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, + AUTOPAS, 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: 6339892
• MDR Text Key: 68021049
• Report Number: 1722028-2017-00040
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

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: 09/01/2018
• Device Catalogue Number: 82321
• Device Lot Number: 09Z9114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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
• Patient Weight: 88