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

Catalog Number 000000000000080520

Device Problem Device Expiration Issue (1216)

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

Event Date 01/05/2015

Event Type  malfunction  

Event Description

The customer reported that a therapeutic hemochromatosis donor underwent a double red blood cell (drbc) collection procedure.The procedure was completed.After the completion of the procedure, they discovered the disposable set that was used had expired on 08/01/2014.Per the customer, the donor left the donor center after the donation and was 'fine'.The error was discovered when a staff member began to install another disposable set of the same lot number on a different machine and noted the disposable set expired.The collected red blood cells were discarded by the customer.Patient's (donor) full identifier is: (b)(6).Patient age and weight are not available at this time.The disposable set was discarded by the customer and is not available for return.This report is being filed due to device malfunction, in the form of operator error, that has the potential for injury.

Manufacturer Narrative

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

Event Description

No medical intervention was required for this event.

Manufacturer Narrative

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.Due to the packaging being undamaged and end caps were in place, there is no risk of sterility.Additionally, since there are no solutions in the set there is no risk of injury to the donor.Root cause: the disposable set was unavailable for specific root cause analysis.A definitive root cause for the customer using an expired set was not determined.Mostly likely, the customer¿s inventory management could have resulted in the set being available for use.Additional information: due to this being an isolated incident and the customer is very knowledgeable of precautionary measures associated with using trima product, no customer training is required.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL RBC, PLASMA, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4442982
• MDR Text Key: 5316363
• Report Number: 1722028-2015-00023
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120017
• 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,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: 000000000000080520
• Device Lot Number: 08U3114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2012
• 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 Age: 48 YR
• Patient Weight: 118