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

Model Number 917000000

Device Problems Component Falling (1105); Positioning Problem (3009)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer's site and a preventative maintenance (pm) was performed.The bearing sleeve was replaced.All tests were completed and the machine is functioning per manufacturer's specification.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima would not stay up.Information of patient (donor) or operator of the device is not known at this time.Outcome of patient (donor) or operator of the device is not known at this time.

Manufacturer Narrative

Investigation: a service call was placed for this event and a terumo bct technicianc hecked out the trima machine at the customer site.The technician noted component wear onthe machine and replaced the iv pole housing assembly.The iv pole bearing sleeve was returned to terumo bct and is currently awaiting evaluation.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer did not return the iv pole bearing sleeve for evaluation, instead the iv pole housing assembly was returned for evaluation.Terumo bct's lab technician was unable to duplicate the reported condition.Upon visual inspection, no anomalies were noted.The trima iv pole was utilized to perform a functional test on the iv pole housing assembly.The functional test on the iv pole housing assembly was successfully completed and the iv pole housing assembly is functioning as designed.It was noted that the iv pole would only slide down when pressing on the latch plate.One year of service history was reviewed for this device with no problems identified related to the reported condition.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of this failure was undetermined.Since the replacement of the referenced part has resolved the issue, it is likely that this part was defective or a contributing factor.Correction: a trima field action 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.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

The trima device was not in use when the failure occured, therefore no patient (donor) or operator information is reasonably known.

• 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: 6500386
• MDR Text Key: 73233345
• Report Number: 1722028-2017-00146
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK010046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2017

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: 917000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017; 07/20/2017
• Supplement Dates FDA Received: 05/12/2017; 06/30/2017; 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other