MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA MACHINE REFURBISHED, FINAL ASSEMBLY

Model Number	81002
Medical Device Problem Codes	Unintended System Motion (1430); Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
During a service call at the customer¿s site, the terumo bct service technician discovered the iv pole on the trima equipment would not stay up.The service technician reported the customer had been using tape to hold it in place.No injury was reported for this incident and no patient was connected at the time the iv pole was discovered, therefore, no patient information is reasonably known.
Additional Manufacturer Narrative
This report is being filed to provide additional information.Investigation: the iv pole and latch plate were not returned for further evaluation, although,the observations of the iv pole not staying up were made by the service representative at the customer site.A new iv pole housing and latch plate were installed in the device.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.Root cause: the root cause of the failure was a defective iv pole.Corrective action: an internal capa has been initiated to address iv poles slipping down and not staying in place.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA MACHINE REFURBISHED, FINAL ASSEMBLY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 7912429
• Report Number: 1722028-2018-00262
• Device Sequence Number: 16557478
• Product Code: GKT
• UDI-Device Identifier: 05020583810020
• UDI-Public: 05020583810020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK150269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: 81002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other