MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET, PLT FILTER, AUTO PAS, PLASMA

Catalog Number 82383

Device Problems Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/18/2019

Event Type  Injury  

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.One platelet collect and storage bag assembly was returned to terumo bct for investigation.Initial observations noted the presence of platelets within one of the collect bags.Both storage bags were empty.Visual examination confirmed that the tubing had come detached from one of the platelet collect bags and the bag was completely empty.The components were further examined under magnification and insufficient solvent application was observed.There were no clear witness marks identified to confirm adequate insertion and no solvent residue could be observed within the collect bag bond socket.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that while performing visual control by candling of the platelet product obtained from a trima device, the collection bag tubing detached.The technician was exposed to the platelet product on the hair, face (wearing glasses) and in the mouth.Per the customer the technicians current state is "nothing to signalize in the immediate future." per the customer the technician completed an accidental work declaration and a medical consultation at the emergency department with start of a serological monitoring of the operator.The customer declined to provide the results of the serological testing.Operator id, age, weight and outcome are not available at this time.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

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause relates to inadequate contact of the tubing with the bond socket after solvent application during the manufacturing process.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.6.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information and outcome are not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLT FILTER, AUTO PAS, PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9341516
• MDR Text Key: 181486440
• Report Number: 1722028-2019-00345
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 82383
• Device Lot Number: 1906192230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 01/06/2020; 02/17/2020
• Supplement Dates FDA Received: 01/24/2020; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention