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

Catalog Number 80537

Device Problems Decrease in Pressure (1490); Use of Device Problem (1670)

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

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Rdf analysis confirmed a ¿draw pressure too low¿ alert was generated about 10 seconds after the operator pressed the ¿start draw¿ button.Analysis showed the ¿continue¿ button never became available on the ¿draw pressure too low¿ alert screen because the aps reading remained below the limit.Since the operator was unable to continue the procedure, the ¿ten minute pause¿ alarm was generated due to possible clotting that could have occurred at the donor access site without ac present.Analysis showed the aps readings were within the expected ranges prior to donor connection.However, when the donor was connected, the aps reading unexpectedly decreased, leading to the ¿draw pressure too low¿ alert.Based on the signals from the run data file, it is possible, though not conclusive, a cassette loading error or variations in the tubing set may have occurred leading to an inadequate interface between the disposable aps diaphragm and machine aps.For example, the cassette may not have been fully snapped onto the cassette plate or an object may have been stuck behind the cassette or cassette plate.With an improper interface between the disposable aps diaphragm and machine aps, it is possible, though not conclusive, the aps reading was below the actual donor venous pressure.The tubing set test was unable to detect this error because it is not designed to test pressure accuracy, only whether the set can achieve and hold certain pressures, ensuring no leak points.Terumobct japan received the set and has confirmed the customer¿s statement and found the following: there was not anything wrong on the returned set.The possible root cause was unknown.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during a collection procedure using a trima device, they received the alarm, 'draw pressure too low'.Through analysis of the run data file by terumo bct, the possibility that the trima aps reading was different from the actual pressures in the tubing set due to a possible misloaded cassette or something stuck between the cassette plate and the aps preventing proper interaction.There is a potential for air to donor.It is unknown at this time if any air was returned to the donor.Patient information and outcome are not available at this time.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: the device history record was reviewed for this lot.There were no issues noted that would have contributed to the air in the set.Correction: due to restrictions related to the covid-19 pandemic, the closeout letter provided to the customer detailing the event and investigation will serve as retraining.Investigation is in process.A follow up report will be provided.

Event Description

Due to japan privacy protection laws, the patient information and outcome are not available from the customer.Patient gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

Root cause: run data file analysis confirmed a ¿draw pressure too low¿ alert was generated about 10 seconds after the operator pressed the ¿start draw¿ button.Analysis showed the ¿continue¿ button never became available on the ¿draw pressure too low¿ alert screen because the aps reading remained below the limit.Since the operator was unable to continue the procedure, the ¿ten minute pause¿ alarm was generated due to possible clotting that could have occurred at the donor access site without ac present.Analysis showed the aps readings were within the expected ranges prior to donor connection.However, when the donor was connected, the aps reading unexpectedly decreased, leading to the ¿draw pressure too low¿ alert.Based on the signals from the run data file, it is possible, though not conclusive, a cassette loading error or variations in the tubing set may have occurred leading to an inadequate interface between the disposable aps diaphragm and machine aps.For example, the cassette may not have been fully snapped onto the cassette plate or an object may have been stuck behind the cassette or cassette plate.With an improper interface between the disposable aps diaphragm and machine aps, it is possible, though not conclusive, the aps reading was below the actual donor venous pressure.The tubing set test was unable to detect this error because it is not designed to test pressure accuracy, only whether the set can achieve and hold certain pressures, ensuring no leak points.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10163008
• MDR Text Key: 200623384
• Report Number: 1722028-2020-00300
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

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: 11/01/2021
• Device Catalogue Number: 80537
• Device Lot Number: 1911215151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 07/20/2020
• Supplement Dates FDA Received: 07/09/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 67