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

Model Number 81000

Device Problem Component Falling (1105)

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

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the iv pole on the trima machine falls down unexpectedly during procedures and disposable installation.Per the customer, no injuries occurred to the operators or donors for this incident.Information of patient (donor) or operator of the device is not known at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a service call was placed and a terumo bct service technician visually inspected the machine at the customer's site.The service technician was able to duplicate the reported condition.Upon visual inspection, the service technician adjusted the security button and functioning as expected.The machine was returned to service.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation:this report is being filed to provide additional information.Investigation: one year of service history was reviewed for this device and two related reports of iv pole dropping down suddenly were found with the incident dates of (b)(6) 2017 (reported on mdr#: 1722028-2017-00215) and (b)(6) 2017 (reported on mdr#: 1722028-2017-00200).A device serial number history report indicates that there were two related reports of the iv pole dropping down suddenly were found in the past year with the incident dates of (b)(6) 2017 (reported on mdr#: 1722028-2017-00215) and (b)(6) 2017 (reported on mdr#: 1722028-2017-00200).Root cause: the root cause of this failure was the push button screw had loosened out of position allowing the iv pole to slip.Correction: trima field action 30 has been initiated to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.

Event Description

The customer declined to provide patient (donor) and operator information since no adverse events occurred.

• 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: 7243889
• MDR Text Key: 99830469
• Report Number: 1722028-2018-00033
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: BK040069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

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: 01/12/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 04/16/2018
• Supplement Dates FDA Received: 03/02/2018; 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other