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

Catalog Number 80440

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

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

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional method code: c91915 data validationinvestigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicatedthat the ¿pressure test error¿ alert was generated in this procedure because the expected pressure increase was not seen in the alotted volume pumped during the tubing set test.Basedon the analysis of the rdf, it is suspected that the pressure increase was not sufficient becausethe pinch clamp on the sample bag line was likely not occluding the line properly.If the clamp onthe sample bag line is not occluding the line properly during the tubing set test, air can have apathway to enter the sample bag.Signals in the rdf also indicated that before the operatorcontinued from the ¿pressure test error¿ alert, rdf analysis showed that the pressure reading atthe access pressure sensor returned to atmospheric.Once the operator continued from the¿pressure test error¿ alert, the tubing set test completed with the expected signals.A service technician visited the customer's site and performed a machine checkout.The machineis functioning per manufacturer's specification.An autotest was successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at the beginning of a collection procedure, they received a¿pressure test error¿ alarm.The operator was not fully followed the prompts instructed on thetrima display screen and continued the procedure.After the venipuncture of the donor, theoperator observed no blood flow and the donor complained of minor pain at thevenipuncture site.While troubleshooting, the operator discovered that the sample bag hadfilled with air and the donor was minor coughing.The donor was transferred to the hospital immediately with good physical condition and tests including x-rays were given to the donor asthe preventive.All the tests showed the donor has good physical condition.Per the customer,the donor has good physical condition since the beginning of this event till (b)(6) 2017.Patient (donor) identifier and age are not available at this time.Patient (donor) gender andweight were obtained from the run data file (rdf).Terumo bct is awaiting return of the trima collection set for evaluation.

Manufacturer Narrative

A partially fluid primed trima collection set was returned in the tray with attached tyvek lidstock.The access needle had been sealed off and detached and was not included with the return.The sample bag appeared full with air and both the white pinch clamps and the blue pinch clamp on the access and sample lines were confirmed to be closed properly with the tubing line fully obstructed.The fluid within the set was only found in the ac line, starting from the spike and had not yet made it back to the inlet line to the cassette.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: according to the aabb technical manual 16th edition,the adverse events seen at the time of the donation or those reported later has average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in1 in 3400 donors.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during follow-up, the customer declined to provide initial reporter occupation and name.The capa information provided in mdr supplement #3 addresses air in the sample bag due to partially occluded tubing and is not applicable to the operator failing to clamp the line to the blood diversion bag as occurred in this event.Root cause: based on the disposable set part evaluation, the service report, and the run datafile analysis of the procedure, the root cause of this failure was an initial failure of the operator to either sufficiently close the clamp on the blood diversion bag or close it at all and then, following the pressure alert, a subsequent failure to follow the screen instructions to look for and express air from the sample bag prior to venipuncture.

Event Description

The customer declined to provide the patient id and age.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: per terumo bct's medical review, the device did not cause or contribute to this incident.Updated root cause: based on the disposable set part evaluation, the service report, and the run data file analysis of the procedure, the root cause of this failure was an initial failure of the operator to either sufficiently close the clamp on the blood diversion bag or close it at all and then, following the pressure alert, a subsequent failure to follow the screen instructions to look for and express air from the sample bag prior to venipuncture.Per terumo bct's medical review,there is insufficient evidence to conclude that the operator's error caused or contributed to the donor's cough that prompted precautionary evaluation for possible air embolus.

Manufacturer Narrative

Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag due to the operator not closing the tubing clamps and failing to follow prompts to express the air out of the sample bag if the clamp was left open.Correction: terumo bct distributor was made aware of the incident and retraining of the site was completed.Further investigational findings on 09/05/2018, confirmed the manufacturer's become aware date was 11/02/2017 instead of 11/04/2017.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7067588
• MDR Text Key: 93246379
• Report Number: 1722028-2017-00458
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K162365
• 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,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1706201230
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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): Required Intervention
• Patient Weight: 57