MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT SAMPLER AUTOPAS PLASMA AUTORBC SET

Catalog Number 82470

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: based on the current available information it is unknown at this time if air is returned to the donor during the pressure test.The reported alarm occurs during ac prime, so the donor should not have been connected at this point in the procedure.In this event, the donor was connect prematurely (indicated by blood in the diversion pouch) and this gives a potential of pushing air back to the donor during the pressure test.The customer provided the photographs of the used trima disposable set to terumo bct for evaluation.Upon photographic inspection, it was confirmed that there was an alarm that occurred as specified by the customer.The reported alarm indicates for ac line obstruction failure-ac occlusion during inlet prime.This alarm checks for ac pump errors and ac occlusion errors and will discontinue the procedure.Also, through pictures it was confirmed that blood and air were interspersed throughout the inlet coil, cassette and return reservoir.The sample line pinch clamp was observed to be closed.The sample bag was full and air was present in the bag.The ac bag frangible appeared to be fully broken and ac was observed within the drip chamber and throughout the ac pump header and inlet coil.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported they had an 'ac line obstruction failure - ac occlusion during inletprime' alarm after the donor was connected to the trima.Per the customer, the only option available was to disconnect the donor and to discontinue the run.Donor information and outcome is not available at this time.The trima disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10 and corrected information in e.1and e.3.Correction: customer retraining on connecting the donor was performed on 3/28/2019.Investigation is in process.A follow-up report will be provided.

Event Description

The customer declined to provide patient information and patient outcome.

Manufacturer Narrative

This report is being filed to provide in investigation: the run data file (rdf) was anaylzed for this event.Root cause: based on the rdf analysis, this alarm #10 occurs during ac priming, where there isno risk for air to be returned to the donor if the donor was connected early.During ac prime,the pumps only run to draw or pull fluid into the cassette, nothing is pushed toward the needleline.The alarm #10, ac line obstruction failure, criteria checks for a decrease in pressure tosignify if the ac line cannot successfully pull fluid.In this case, the pressure signals increased whenthe donor was connected at the prompt to connect ac, then decreased with the pumpmovement during ac prime.The decrease in the pressure signals matched the signals as if ac fluidflow was not satisfactory.The alarm forces the operator to terminate the procedure, socontinuing to the first return is also not possible.Based on the information provided, rdf analysis, the evaluation of the returned disposable, andthe reported alarm this occurrence was due to premature connection of the donor.This isconsidered a user interface error.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT SAMPLER AUTOPAS PLASMA AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8443904
• MDR Text Key: 139822633
• Report Number: 1722028-2019-00064
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824706
• UDI-Public: 05020583824706
• Combination Product (y/n): N
• PMA/PMN Number: BK170157
• 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: 03/22/2019

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: 06/01/2020
• Device Catalogue Number: 82470
• Device Lot Number: 1806252230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/29/2019; 05/21/2019
• Supplement Dates FDA Received: 04/16/2019; 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other