MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET

Catalog Number 80400

Device Problems Device Alarm System (1012); Leak/Splash (1354); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 04/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used disposable set with attached red blood cell (rbc) bag was returned to terumo bct for investigation.Upon visual inspection, it was found that the rbc bag was dry of any fluid and showed no residue, indicating that it was not used.The plasma and platelet collection bags were not returned with the set.On evaluation of the entire set, dried blood was found near the center of the braid on one side.The channel welds, loop to channel tubing line bonds, rbc control y, and lrs chamber were closely evaluated for any evidence of a leak,with none observed.The channel and loop assembly were separated from near the cassette bonds and flushed to clear the lines and components of blood.The entire assembly was pressurized with air up to approximately 30 psi with no visible leak location found.The rbc control y and lrs were then separated and pressurized with air independently up to approximately 50 psi with no leak observed.The channel was then filled with dyed water to observe any saturation of a weld leak.A small area on the lower weld of the collect connector was observed with a slight defect and nearby was found a light line of blood residue that could not be wiped away indicating a potential leak path within the weld.The channel was placed in a filler plate and pressurized up to 50 psi to attempt a flush of the residue plugging the leak path.A leak was confirmed at the weld in this location.Based on the close up images of the returned channel, there appears to be an approximately 1 mm wide weld bead interruption.Likely during the run, there was a high stress concentration at the weld bead interruption that propagated into a small leak path in the perimeter weld measuring around 0.5 mm wide.The run data file (rdf) was analyzed for this event.Review of the run data file confirmed that at 17 minutes, a ¿leak detected¿ alert was generated and the operator pressed the¿continue¿ button.Signals in the rdf indicate that the leak detector detected a leak and alerted the operator, but the procedure was continued without any intervention.Technical staff at the customer site successfully ran testing for the leak detector from the bottom of the leak detector to the top.No issues were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a patient underwent a collection procedure on the trima machine without any alarms.Per the customer, a leak was discovered in the centrifuge after the procedure was completed.The customer is alleging a possible bacterial contamination of the product.No medical intervention was required for this event.The customer declined to provide patient (donor) identifier id and age.Patient's gender and weight were obtained from the run data files (rdf).Patient outcome is unknown at this time.

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.There was no report of actual microbial contamination, the customer is only concerned due to leak.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: per returned set investigation, the leak was determined to be due to a manufacturing error.Review of the run data file confirmed that the system operated as intended by generating the appropriate alert of 'leak detected' at 17 minutes.

Manufacturer Narrative

This report is being filed to provide additional information that was missing from the initial submission.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7527308
• MDR Text Key: 109235480
• Report Number: 1722028-2018-00139
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: BK170059
• 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
• Report Date: 05/18/2018

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 Expiration Date: 10/01/2019
• Device Catalogue Number: 80400
• Device Lot Number: 1710273230
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/11/2018; 10/25/2016
• Supplement Dates FDA Received: 06/12/2018; 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95