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

Catalog Number 80440

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

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

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The rdf showed that procedure was never started.The procedure was ended shortly after donor information was transferred but 'start draw' was never pressed.One 'pressure test error' alarm occurred during the cassette test.A used trima disposable set was returned for investigation.Upon visual inspection, it was noted that the sample bag and all product bags were removed and not returned with the rest of the set 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.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 that during a platelet collection procedure on a trima device, theoperator noticed that the sample bag was filled with air.The customer stated they had a'pressure test error' alarm during prime, however they continued the procedure after they cleared the alarm.Per the customer, while drawing the pre collection samples, the operator noticed air in the sample bag and stopped the procedure immediately and disconnected the donor.They searched for a leak on the outside of the disposable kit and the sample bag and found none.Per the customer, the donor is reported to have no 'side affects' from the incident.Full patient (donor) identifier: (b)(6) patient age information is not available at this time.

Event Description

No medical intervention was required for this event.

Manufacturer Narrative

This report is being filed to provide in investigation: in an attempt to recreate what the customer experienced, an unused trimadisposable was loaded onto the trima in the lab.The operator was instructed to clamp theneedle line and the sample bag line before the cassette was lowered.The investigator closed thewhite pinch clamp on the donor needle line, and intentionally left the white pinch clamp on thesample bag open.The machine then verified that the clamps were closed by briefly turning onthe return pump and checking for an increase in pressure.Due to the open sample bag clamp,the pressure test failed and the sample bag filled slightly with air.The operator was prompted toverify that the clamps were closed and no air was in the sample bag.If the air is not removedfrom the sample bag but the clamp closure error is corrected, the tubing set test will pass.Whena donor is connected and the sample bag clamp is opened to obtain samples, air can be returnedto the donor.Correction: terumo bct customer support contacted the customer to offer retraining.Thecustomer stated she would speak with technician involved.The customer did not provide furtherresponse regarding retraining.Root cause: based on the clinical findings, disposable set evaluation, and run data analysis, the¿pressure test error¿ alert was generated in this procedure because the expected pressureincrease was not seen in the allotted volume pumped during the tubing set test, indicating eitherthe sample bag and/or needle line clamps were not closed at the system prompt, or the clampwas closed, but it was skewed on the tubing, allowing a portion of the tubing to allow air to pass.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8612710
• MDR Text Key: 145536563
• Report Number: 1722028-2019-00112
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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 Expiration Date: 01/01/2021
• Device Catalogue Number: 80440
• Device Lot Number: 1901224151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00057 YR
• Patient Weight: 105