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

Catalog Number 80520

Device Problems Device Expiration Issue (1216); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

Full reporter's email : (b)(6).Investigation: the laboratory manager verified that no other donors were drawn using this lot number since 06/01/2016.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that they successfully completed a double red blood cell collection on a donor, and post-donation, realized that they had used an expired collection kit.The set expired on 06/01/2016.The donor is in stable condition.Full patient (donor) identifier: (b)(6).The collection kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.A possible root cause is related to the customer¿s inventory management that could have resulted in the set being available for use.Correction: follow-up with the customer was performed and the customer is aware of product expirations potentials associated with using an expired set.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC, 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: 5910415
• MDR Text Key: 54284173
• Report Number: 1722028-2016-00478
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130080
• 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
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• 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: 80520
• Device Lot Number: 06W3309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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: 50 YR
• Patient Weight: 113