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

Model Number 81000

Device Problems Computer Software Problem (1112); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Human Factors Issue (2948)

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

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: with the donor's tbv of 5829ml, the donor would not have qualified for the procedure.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the vista software system.The operator initially entered the donor's height as (b)(6) instead of (b)(6).The customer then miscalculated the donor's height by converting the donor's height in inches using their blood bank information software system into feet and inches using the vista software system.They miscalculated and completed the procedure on the donor at (b)(6) rather than (b)(6).The vista software system also calculated the total blood volume (tbv) with the incorrect height as 6985ml instead of the donor's actual total blood 5829ml.No medical intervention was required for this event and no additional follow-up visit was necessary.Per the customer, the donor felt 'fine' after the procedure.Full patient (donor) id: (b)(6).

Manufacturer Narrative

Investigation: a service call was placed and a full machine checkout was performed.The machine is functioning per manufacturer's specification.The customer returned a used collection set for investigation.Upon visual inspection, it was observed that all lines including the 4 lumen tubing for the loop were detached.The collection set was inspected for misassemblies and other defects.No defects were identified.One year of service history was reviewed for this device with no issues related to the reported condition identified.An internal report shows that the machine has been in use with no further occurrences of the problem.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: during customer follow-up, the customer stated that a corrective action was taken per policy at the customer's site.Root cause: user interface issue; run data file analysis confirmed that the patient information was entered incorrectly.The operator entered (b)(6) instead of (b)(6).Correction: terumo bct support specialist retrained the customer.

• 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: 5923317
• MDR Text Key: 54465211
• Report Number: 1722028-2016-00493
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100032
• 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,Followup
• Report Date: 09/01/2016

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: 81000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/22/2016; 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2010
• 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: 00056 YR
• Patient Weight: 106