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

Model Number 81000

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958); Patient Data Problem (3197)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

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 allogeneic platelet donation procedure.The operator entered the donor height and weight as (b)(6) when the actual donor height and weight is (b)(6).The error was not discovered until post donation.No medical intervention was necessary for this event.The donor is reported in healthy condition.Patient's (donor) full identifier: (b)(6).Patient (donor) age is not available at this time.The platelet donation set is not available for return because it was discarded by the customer.

Manufacturer Narrative

A terumo bct's system engineer performed a calculation for the potential for ac over infusion and hypovolemia for this event.The calculated ac infusion rate for both the entered and correct patient data are less than the maximum allowed ac infusion rate per the version 6.0 trima accel system administrator¿s guide.Therefore, it is unlikely that an ac overinfusion occurred due to the incorrectly entered donor information.Based on the trima accel automated blood collection system administrator's guide, the total volume removed from the male donor for both the entered and correct patient data resulted in less than 15% tbv being removed.One year of service history was reviewed for this device with no similar issues to the reported condition identified.Root cause: the root cause has been determined to be a user interface issue.

Manufacturer Narrative

Additional investigation: further evaluation of this event has determined that the devicedid not cause or contribute to a death or serious injury, nor is there a likely potential for death orserious injury associated with this event based on additional investigational information.A terumobct's system engineer performed a calculation for the potential for ac overinfusion andhypovolemia for this event.The calculated ac infusion rate for both the entered and correctpatient data are less than the maximum allowed ac infusion rate per the version 6.0 trima accelsystem administrator¿s guide.Therefore, it is unlikely that an ac overinfusion occurred due to theincorrectly entered donor information.Based on the the trima accel automated blood collectionsystem system administrator's guide, the total volume removed from the male donor for boththe entered and correct patient data resulted in less than 15% tbv being removed.

Event Description

The customer declined to provide patient (donor) age.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6498809
• MDR Text Key: 73257868
• Report Number: 1722028-2017-00145
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• 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: 04/17/2017

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
• Other Device ID Number: 05020583810006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2017; 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2013
• 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: 102