MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 917000000

Device Problem Patient Data Problem (3197)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: using the donor's correct height and the center's configuration, this donor would not have qualified to donate this procedure due to post platelet and length of run.The most he qualified for was a 8.5x10^11 platelet with a single rbc.With the entered information, a9.6 x 10^11 triple platelet product was collected.The customer stated that they will collect a pre-platelet count before he donates again.The end of run summary was given to the customer, along with feedback regarding the incorrect data entry of patient data.A one year review of the device's service history was performed with no issues noted that were related to the reported condition.No further related issues have been reported for this device.Root cause: the root cause for the incorrect height and weight of the donor is a user interface issue.

Event Description

During review of run data files (rdfs) for an unrelated customer request, terumo bct found an incident of donor data entry error.In the rdf, it was noted that the height of a donor had been entered incorrectly.Actual donor height: (b)(6) donor height entered: (b)(6) no medical intervention was required for this event and the donor felt well when he left the center.Full patient identifier: (b)(6).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5486366
• MDR Text Key: 40206823
• Report Number: 1722028-2016-00114
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK990025
• 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
• Report Date: 03/08/2016

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 Model Number: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2000
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 105