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

Model Number 81000

Device Problems Collapse (1099); Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 12/07/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed to provide additional information.Corrected information is provided.Investigation: per customer follow-up, it was reported that there was no exposure that occured related to the hole in the bloodline that occured during this event.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no other problems identified related to the reported condition.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Implementation of the addition of a collar for the currently field installed devices will be completed to address this issue." root cause: the root cause of this failure was a misaligned internal setting screw on the iv pole.

Event Description

The customer declined to provide age and weight.Per follow up with the customer it was confirmed that no medical intervention was required for this event.

Manufacturer Narrative

Investigation: per the customer, the iv pole collapsed causing a hole in the bloodline and the unit to become "contaminated".The units were discarded.The safety collar was attached and functioned as designed as reported by the customer.A terumo bct service technician checked out the machine at the customer site and confirmed the iv pole is not staying in place, dropping with pressure is applied.The service technician adjusted the internal setting screw and verified the iv pole stays in place and is working properly.The device was returned to service.The iv pole clamp was installed on this device in 12/2018 during a semi-annual pm per manufacturer specifications.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that when disconnecting the red blood cell (rbc) unit from the device, the iv pole on the trima equipment collapsed.There was no injury to the staff or to the donor.Patient information is not available at this time.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: gary dark ; 10810 w. collins ave; lakewood, CO 80215 ; 3035425102
• MDR Report Key: 9521730
• MDR Text Key: 177882859
• Report Number: 1722028-2019-00438
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other