MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER

Catalog Number 000000000000080483

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

The customer reported that the welding broke off the 'platelet cone' near the tubing.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable set is not available for return because it was discarded by the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and investigation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The trima accel automated blood collection system operators manual states that ¿if the integrity of the tubing set is compromised, the tubing set is no longer functionally closed and the product should not be stored beyond 24 hrs.¿root cause: the disposable set was unavailable for return and analysis, a definitive root cause could be determined.It is possible, based on the customer provided information, that this was the result of a manufacturing assembly defect related to excess solvent between the tubing and the lrs chamber port.

Event Description

No medical intervention was necessary 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 PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4251106
• MDR Text Key: 5044335
• Report Number: 1722028-2014-00455
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK130080
• 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: 10/21/2014

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: 000000000000080483
• Device Lot Number: 06W2105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 11/14/2014
• 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: 06/04/2014
• 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