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

Catalog Number 80440

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they noticed a clot in the needle during a collection procedure.While the operator opened the clamp, they noticed that there was no blood flow.The customer stated that they had trouble establishing flow and by that time the needle had clotted.It is unknown at this time if medical intervention was necessary for this event.Patient information is unavailable at this time.Patient outcome is unavailable at this time.The disposable set is not available for return because it was discarded by the customer.

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.The customer stated that the cause of the clot was due to poor venipuncture and the disposable set and system is not the source of this issue.The run data file (rdf) was analyzed for this event.The rdf analysis showed that the operator never pressed " start draw" to begin the collection.Root cause: per customer statements, the root cause for the clotted needle was due to poor venipuncture.

Event Description

The customer declined to provide the patient's (donor) identifier and age.No medical intervention was required for this event and the patient (donor) and no additional follow-up visit was necessary.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5027701
• MDR Text Key: 24802147
• Report Number: 1722028-2015-00500
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/31/2015

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: 06/01/2017
• Device Catalogue Number: 80440
• Device Lot Number: 06Y1130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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
• Patient Weight: 109