MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, PLT FLTR, AUTO PAS, PLASMA SET

Catalog Number 82383

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Thrombus (2101)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during a donation procedure, they noted blood not returning to the donor.When the needle was removed, a clot was found at the needle.Donor outcome is not known at this time.Due to eu patient privacy protection laws, the patient (donor) information is not available from the customer.The disposable set is unavailable for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return.The customer was not able to provide additional details of the machine or the procedure.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the needle clot experienced by the customer.Root cause: the definitive cause of the clot at the needle could not be determined.Clotting at the needle can occur from, but is not limited to, an inadequate ac ratio, use of the incorrect solution, a kinked or an occluded ac line, incorrect ac pump delivery, a poor needlestick, anda hypercoagulable apheresis donor.

Event Description

The customer declined to provide any further procedure details.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLT, PLT FLTR, AUTO PAS, 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: 5399920
• MDR Text Key: 37241339
• Report Number: 1722028-2016-00039
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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: 08/01/2017
• Device Catalogue Number: 82383
• Device Lot Number: 08Y2107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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