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

Model Number 917000000

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure on trima they inadvertently collected a partial platelet product and two red blood cell (rbc) products.The staff member started a platelet collection and made a change during the procedure.They intended to select a platelet procedure that would require less time, but they selected the double rbc procedure.It is unknown at this time if medical intervention was required for this event.Patient (donor) age and outcome are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.Corrected information is provided in d.2, d.4 udi# and expiration date are intentionally left blank, h.4, h.5, h.8 and g.5.Investigation: one year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Root cause: the root cause of this failure was two separate software issues: one for the drbc being reallowed during the procedure and one for a drbc collection being collected in addition to a platelet volume.

Event Description

The customer provided the donor id, weight, and gender; however, they did not provide the donor's age.The customer confirmed the donor did not experience any adverse effects due to this incident.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10017519
• MDR Text Key: 190065181
• Report Number: 1722028-2020-00197
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• PMA/PMN Number: BK030083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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 Expiration Date: 09/01/2021
• Device Model Number: 917000000
• Device Catalogue Number: 82446
• Device Lot Number: 1909274151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 69