MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA MACHINE,FINAL ASSY, CHINA

Model Number 81011

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the terumo bct service representative tested the machine at the customer site and no issues were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported over collection on a trima machine.The information for the investigation such as procedural details and patient information and outcome is not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that the device flagged to verify the platelet volume and on the basis of the available procedure summary it was also confirmed that the fluid balance was within the specified limits at 94%.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.Investigation is in process.A follow-up report will be provided.

Event Description

Patient id, age and outcome are not available at this time.Patient gender and weight obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide in correctedinformation is being provided in e.3.Root cause:a definitive root cause could not be determined.Possible causes include but arenot limited to:¿ entry of incorrect donor characteristics including platelet precount, hematocrit, height andweight.¿ incorrectly configured machine variables (i.E.Target volume not accurate, inaccurate yield scalingfactor).¿ excessive pressure alerts regarding donor venous access issues.¿ numerous adjustments to flow rates or other procedural inputs/parameters during theprocedure.¿ failure to follow screen prompts to clamp off platelet bag when collecting double or tripleproduct.¿ use of improper tare weight and/or specific gravity to calculate product volume.¿ use of a scale or cell counter that is not calibrated.

Event Description

Patient outcome information was not provided by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE,FINAL ASSY, CHINA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8345594
• MDR Text Key: 137017637
• Report Number: 1722028-2019-00037
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

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: 81011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 03/11/2019; 03/14/2019
• Supplement Dates FDA Received: 03/12/2019; 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100