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

Catalog Number 80500

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Operational Issue (2914)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf showed that the system operated as intended.The disposable set with attached plasma bag and detached rbc bags was returned for evaluation.The disposable was visually evaluated for any mis-assemblies, obstructions, leaks, or other defects with none found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they inadvertently selected a plasma collection procedure instead of a double red blood cell (drbc) collection procedure from the trima display screen.Per the customer, after collecting 65 ml of plasma, it was then discovered that the incorrect procedure was selected.No medical intervention was required for this event.The customer stated that the patient (donor) is 'fine'.Patient's (donor) (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: an unused red blood cell (rbc) bag was used as a tare weight within the lab so that the returned rbc bags could be measured.The 1st returned rbc bag weighed 507.4g and the 2nd rbc bag weighed 289.6g.An internal report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no problems identified related to the reported condition.Terumo bct's support specialist performed a calculation on the approximate anti-coagulant (ac) infusion rate and determined that although the wrong procedure and incorrect height and weight was incorrectly selected, the donor did not experience a cover infusion or hypovolemia.It was calculated that the donor did not have less than 15% tbv removed during the procedure and the donor's ac infusion rate was lower than the maximum for the specified procedure time.Root cause: the root cause of this failure was undetermined.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6505371
• MDR Text Key: 73461821
• Report Number: 1722028-2017-00152
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 80500
• Device Lot Number: 12Y1222
• Other Device ID Number: 05020583805002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2015
• 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 Age: 33 YR
• Patient Weight: 113