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

Model Number 81000

Device Problems Use of Incorrect Control/Treatment Settings (1126); Programming Issue (3014)

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

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The trima accel system uses the entered donor information to ensure that the targeted products can be safely and efficiently collected within the trima accel safety box.If incorrect donor information is entered into the system, the system could collect products that are outside these limits, particularly maximum donation volume, minimum post-donation platelet count, minimum post-donation hematocrit and maximum ac infusion rate.Based on the available information, the entered weight of 220 lbs (tbv: 6,253 ml), when compared to the donor¿s actual weight of 218 lbs (tbv:6,223 ml), did not likely exceed any of these safety limits.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the trima system for a double platelet collection procedure.The customer entered the donor's weight as (b)(6) when the actual weight is (b)(6).The error was not discovered until post collection.No medical intervention was necessary for this event.The donor is reported in healthy condition.Patient's (donor) full identifier: (b)(6).The customer declined to provide the donor's age.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: entering in a donor weight of (b)(6) lb instead of the actual weight of (b)(6) lbs will result in a shift of the final fluid balance and in this case, it was calculated to be (b)(4)%.Therefore the data entry error did not result in an over depletion of greater than (b)(4)% of tbv.The customer acknowledged the investigative results of this event, including the risks associated with inputting an incorrect donor weight.Root cause: user interface issue.The operator entered the incorrect weight of donor.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5089245
• MDR Text Key: 26501539
• Report Number: 1722028-2015-00556
• 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: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 81000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 99