MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER,AUTOPAS ,MLT PLASMA SET

Catalog Number 82310

Device Problems Backflow (1064); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Headache (1880); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the ¿pressure test error¿ alert was generated because the pressure in the tubing set could not be maintained.Possible causes include but are not limited to: failure to close the white clamp on the sample bag line, or the white clamp on the sample bag line did not occlude the tubing during the first pressure test.If the operator does not close the clamps on the tubing set when instructed by the system, or if the clamps do not properly occlude the tubing during the tubing set test, air may be introduced into the sample bag.If this occurs, the trima accel system will alert the operator to a failure during the tubing set test.This alert will instruct the operator either to express air from the sample bag if it is inflated, or to verify that no air is in the sample bag.Information screens that are accessible from the alert screen will instruct the operator how to express air if the sample bag is inflated.Run data file analysis did not show that the operator opened the clamps to remove air from the sample pouch after the alert was shown.A used trima collection set was returned for investigation.Upon visual inspection, it confirmed the presence of prime fluid throughout the inlet coil.A small amount of blood was observed in the donor line and sample bag (<10ml).The sample bag was inflated with a volume of air measured at approximately 80ml.No disposable defects were identified.The donor, inlet and sample line pinch clamps were closed.A service technician visually inspected the machine at the customer's site.The machine is functioning per manufacturer's specification and no issues were found.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during setup for a collection procedure, they received multiple pressure alarms.Per the customer, the technician checked the clamps prior to phlebotomy and continued the procedure.Post-phlebotomy, she noticed blood went into the sample bag and the sample bag filled with air.She immediately closed the clamps and noted the blood flow was diverting back to the donor.The procedure was discontinued.Post procedure, the donor's respiratory rate increased and the donor complained of malaise,a cute short-term dyspnoea, and a mild headache.Per the customer, the donor's respiratory rate and oxygen (o2) saturation was monitored for approximately 30 minutes and the physician discharged the donor.Patient (donor) identifier and age are not available at this time.Patient (donor) gender and weight were obtained from the run data file (rdf).This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

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.Root cause: the ¿pressure test error¿-alert was generated because the pressure in the tubing kit could not be maintained.Possible causes include but are not limited to: failure to close the white clamp on the sample bag line or the white clamp on the sample bag line did not occlude the tubing during the first pressure test.Once the air was in the set, the review of the run data file indicated that the air was not fully evacuated from the disposable set when indicated by the pressure alert.This could be due to not opening the clamp on the sample bag line or fully expressing the air out of the bag.If the operator does not close the clamps on the tubing set when instructed by the system, or if the clamps do not properly occlude the tubing during the tubing set test, air may be introduced into the sample bag.If this occurs, the trima accel system will alert the operator to a failure during the tubing set test.This alert will instruct the operator either to express air from the sample bag if it is inflated, or to verify that no air is in the sample bag.Information screens that are accessible from the alert screen will instruct the operator how to express air if the sample bag is inflated.Run data file analysis did not show that the operator opened the clamps to remove air from the sample pouch after the alert was shown.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

Event Description

Due to eu personal data protection laws, the patient identifier and age are not available from the customer.

Manufacturer Narrative

This report is being filed to correct information.

Manufacturer Narrative

Additional root cause: based on the evidence from the part evaluation in conjunction with dlog analysis, the root cause was determined to be due to operator error.When the set was returned it was noted that the sample bag was inflated with a small volume of blood present in the sample bag.This confirms what was indicated in the dlog analysis, that the air was not expressed from the sample bag by the operator as directed by the trima when the pressure test error was generated.Correction: feedback was provided to the customer regarding the potential of user error in this incident.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER,AUTOPAS ,MLT 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: 7111457
• MDR Text Key: 95744250
• Report Number: 1722028-2017-00481
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2017

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: 06/01/2019
• Device Catalogue Number: 82310
• Device Lot Number: 1706191130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 04/30/2018; 10/26/2018
• Supplement Dates FDA Received: 01/25/2018; 05/01/2018; 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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: 91