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

Catalog Number 80337

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012); No Apparent Adverse Event (3189)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file did not show a definitive root cause for the ¿centrifuge pressure high¿ alerts generated in this procedure.Following the first ¿centrifuge pressure high¿ alert, the pressure was relieved when the centrifuge was stopped.The second ¿centrifuge pressure high¿ alert was generated shortly after the operator continued from the first alert.Possible causes of high recurring centrifuge pressure are: air entering the inlet line or occluded loop tubing lines.The disposables set was returned to terumo bct japan for evaluation.Tbct japan confirmed the customer¿s statement and found the following: the possible root cause was customer error,the possible root cause was diversion bag line tubing was not completely clamped and air in the diversion bag line tubing flowed into centrifuge.There was pressure on diversion bag.Corrective action: an internal capa has been initiated to address air in the sample bag.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure on the trima machine, they received an alarm centrifuge pressure high- centrifuge pressure too high alert.During evaluation by terumo bct, it was found that the sample diversion bag contained an excess of air.Per the customer the donor was reported as "ok", no air was returned to the donor and the event did not require any medical intervention.Due to personal data protection laws in japan, the donor information is not available from the customer.Donor gender and weight were obtained from the run data files (rdf).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

Investigation: tbct (b)(4) returned the disposable to terumo bct lakewood for evaluation: a used trima inlet access assembly was received for investigation.It was noted that the needle,sample bag assembly, and inlet coil were removed and not returned to aid in the investigation.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.No bond gaps or bond voids were found in the bonds.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

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.Further investigation determined the sample bag was filled with blood and not air.It was confirmed that no air was returned to the donor.Tbct japan submitted pictures of the disposable set.The pictures showed the complete set with blood throughout the tubing.The pictures showed the diversion bag was bulging with blood inside and a few small air bubbles.The pictures also showed the blue one- way clamp on the diversion line was closed as well as the white pinch clamp.The inlet tubing portion with the clamps was removed and submerged under water.Fluid was introduced with a syringe and the pictures confirmed the blood would not flow past the clamps.Once the clamps were opened, the pictures showed blood was able to flow out normally.The pictures included an image of the inlet coil.There were no visible air bubbles.Air bubbles and pockets of air were present starting at the access pressure sensor (aps) and continuing to the inlet pump header, through the centrifuge pressure sensor (cps) and 4 lumen down into the channel, back up to the cassette to the return line to the reservoir as well as the platelet pump header tubing.However, this is not unusual once the set has been unloaded and handled.If the air pockets and bubbles were present during the procedure, they may have contributed to the centrifuge pressure alarm the customer experienced.There were no visible bubbles or air pockets in the return line from the reservoir.Corrected corrective action: the capa information provided in the initial mdr is no longer applicable to this event, as it was determined there was no concern for air to donor.Root cause: review of the run data file did not show a definitive root cause for the¿centrifuge pressure high¿ alerts generated in this procedure.Following the first ¿centrifuge pressure high¿ alert, the pressure was relieved when the centrifuge was stopped.The second ¿centrifuge pressure high¿ alert was generated shortly after the operator continued from the first alert.Possible causes of high recurring centrifuge pressure are:-air entering the inlet line-occluded loop tubing lines.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8232143
• MDR Text Key: 133530003
• Report Number: 1722028-2019-00007
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

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 Expiration Date: 07/01/2020
• Device Catalogue Number: 80337
• Device Lot Number: 1807165151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 01/15/2019; 02/11/2019
• Supplement Dates FDA Received: 02/01/2019; 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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: 81