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

Catalog Number 000000000000080300

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The customer reported that during the donation, the anticoagulant (ac) tubing disconnected from the set near the filter.Due to eu personal data protection laws, the patient information is not available from the customer.This report is being filed in response to the customer filing an sae report with their local authorities.

Manufacturer Narrative

Investigation: the disposable kit was returned for investigation.Visual inspection shows the tubing to the top of the ac filter was detached from the top bond socket.Solvent marks appear to show inadequate insertion of the tubing into the filter bond socket.Investigation is in process.A follow-up report will be provided.

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.Root cause: based on the customer's returned tubing set inspection results, the root cause is most likely a manufacturing assembly issue.

Event Description

No injury was reported for this event.

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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4190292
• MDR Text Key: 4983408
• Report Number: 1722028-2014-00426
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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
• Report Date: 09/26/2014

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: 06/01/2016
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 06W2219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other