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

Catalog Number 000000000000080300

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

The customer reported that they received a 'draw pressure low' alarm approximately 8 minutes after the venipuncture for a collection procedure.The operator then noticed a clot in the needle.The operator ended the collection.It is not known at this time if medical intervention was required for this event.Patient information is not available at this time.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to the potential for injury if the same failure were to reoccur.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this event.There are no issues noted in the dhr that would have contributed to the reported clotting in the needle experienced by the customer.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Root cause : the disposable set was unavailable for specific root cause analysis.Signals in the run data file analysis confirmed multiple consecutive ¿draw pressure too low¿ alerts occurred early in the procedure during the blood priming sequence.Root cause is inconclusive but pressure alerts this early in the procedure are generally indicative of the venous access requiring adjustment and not of clumping at the needle.Terum bct is in-process of coordinating training for operators at the customer site, regarding venous access and adjustment.

Event Description

The customer stated that they were unable to recall the donor's id or age.The donor's gender and weight were obtained from the run data file.The donor had no symptoms and no medical intervention was required 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 PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4266877
• MDR Text Key: 5005872
• Report Number: 1722028-2014-00471
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 10/30/2014

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: 05/01/2016
• Device Catalogue Number: 000000000000080300
• Device Lot Number: 05W2117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2014; 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2014
• 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
• Patient Weight: 90