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

Catalog Number 80440

Device Problems Misassembled (1398); Defective Component (2292); Appropriate Term/Code Not Available (3191)

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

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the reported event.In lieu of the disposable set, the customer provided photographs to terumo bct for evaluation.The pictures confirmed that the bacterial filter on the ac tubing was assembled upside down.Asa result, air was pulled through the vent hole when the ac pump started to pump the ac fluid from the bag.Based on the images, there were air bubbles in the both the inlet and the return lines at the time that the prime sequence was ended.The air bubbles in the inlet line would have likely traveled to the channel, created air block and triggered a centrifuge pressure high alarm.Correction: manufacturing staff were made aware of this incident and retrained to the appropriate procedures.Investigation is still in process, a follow-up will be provided.

Event Description

The customer reported that during ac prime, they noticed a defect with the acda filter and air bubbles were pulled into the ac, draw and return lines.There was no donor involved at the time of the ac prime, therefore, no donor information is reasonably known at the time of this event.The trima disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: after multiple attempts for follow-up, the customer declined to provide the initial reporter's name and occupation for this event.The run data file (rdf) was analysed for this event.Run data file analysis showed the ac priming sequence completed without alerts.Analysis also showed that the ac sensor detected fluid throughout the entire ac priming sequence.The operator selected to terminate the procedure prior to drawing blood from the donor.The start draw button was never pressed.Since air was entering the system through the ac line, the risk of returning air to the donor was evaluated.The ac pump never pushes fluid directly to the donor, however the inlet pump and return pump pull from the ac line into the system.Therefore, these pathways were considered for the potential of air to be returned to the donor.Air that enters the inlet line will be processed through the centrifuge and will be diverted to the reservoir/vent bag, in which there is no donor risk.For ac prime and blood prime, the return pump runs backward, pulling fluid into the lines.Some of this fluid will enter the reservoir, and therefore any air will be diverted into the vent bag.The rest of the fluid will be returned to the donor during the first return cycle.As such, this was the pathway evaluated for the risk of air to the donor.During the ac priming sequence in this procedure, the return pump was shown to have pulled 1.25ml into the return line.Worst case, an ¿ac prime failure¿ alarm shuts down the procedure during ac prime after 7ml of volume has been pulled into the return line.The average volume of blood and ac pulled into the return line during the blood priming sequence is approximately 30ml.Worst case, a ¿low-level sensor failure¿ will shut down the procedure after 45ml of volume has been pulled in.Referring to the prior run rdf, the ac pump ran 7.25% slower than the return pump.In an average procedure, that means approximately 2.175ml (7.25% *30ml) of air is possible to be pulled in the return line during the return line priming.In a worst-case procedure, that means approximately 3.2625ml (7.25% * 45ml) of air has the potential to be pulled into the return line during the return line priming.Bolus of air that would have likely been returned to the donor in the first return cycle if the donor were connected in this procedure:1.25ml + 2.175 = 3.425ml /50kg (lowest estimated donor weight) = 0.0685ml/kgbolus of air that would have likely been returned to the donor in the first return cycle if the donor were connected in a worst-case scenario:7ml + 3.2625 = 10.2625ml /50kg (lowest estimated donor weight) = 0.20525ml/kg.Based on these calculations, the risk of injury for this event is none.Root cause: the cause of this defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

Manufacturer Narrative

This report is being filed to provide additional information.Several attempts were made to obtain the initial reporters name and title and customer declined to provide this information.

• 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 ; 3032392245
• MDR Report Key: 7726106
• MDR Text Key: 115532872
• Report Number: 1722028-2018-00206
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2018

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: 02/01/2020
• Device Catalogue Number: 80440
• Device Lot Number: 1802021230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 08/15/2018
• Supplement Dates FDA Received: 08/21/2018; 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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