MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, PLT FLTR, AUTO PAS, PLASMA, SET

Catalog Number 82383

Device Problem Detachment Of Device Component (1104)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the platelet bag from the trima set was returned for inspection(the detached tubing was not received).Inspection of the bond port confirmed that the tube stub on the bag had no solvent present.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while the operator was performing air purge of the collection bags,one of the tubings connected to the collection bag detached itself from the bag, which resulted in blood exposure to the operator.Due to eu personal data protection laws, the patient information is not available from the customer.

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.Per the customer, the blood exposure came in contact of the operator's lips, eyes, and nose.The operator received an occupational medicine consultation by a physician and blood sampling for serological monitoring.Root cause: based on the part evaluation, the leak was the result of insufficient solvent between the tubing and the bond port, which is a manufacturing assembly issue.

Event Description

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

Additional information: per the customer, serology testing was performed on the donor blood sample and the results did not indicate any issues with the donor's blood.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, PLT FLTR, AUTO PAS, 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: 5414606
• MDR Text Key: 38249856
• Report Number: 1722028-2016-00044
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK140180
• 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: 02/05/2016

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: 08/01/2017
• Device Catalogue Number: 82383
• Device Lot Number: 08Y2128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2016; 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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