MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

Catalog Number 000000000000080440

Device Problems Leak/Splash (1354); Failure to Prime (1492); Device Displays Incorrect Message (2591); Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 07/14/2014

Event Type  Injury  

Event Description

The customer reported that an unknown amount of air was returned to a donor during a platelet collection procedure.During prime for the procedure, they received multiple alarms and were prompted to reload.The technician appears to have clamped the needle line as prompted by the machine, but it appears the sample bag clamp may not have been closed or only partially occluded when they reloaded.The tech mentioned that one of the clamps did not appear to be fully closed when they reloaded.The sample bag was filled with air.When the customer phlebotomized the donor, they noticed a blood flash.When they opened the sample bag, the air pushed the blood back to the donor.The technician clamped the line and pulled the needle.They contacted the medical director who instructed them to take her to the er.The er staff described the right forearm as puffy and larger in size.The er listed the injury as a subcutaneous emphysema due to air infiltration, and treated the arm with warm compress and percocet.The donor was then released from the emergency room.Upon follow-up 24 hours later, the donor reported that she was feeling good.This report is being filed due to medical intervention via the patient being taken to the emergency room.

Manufacturer Narrative

Investigation: the disposable set containing prime fluid was returned for investigation.The following observations were noted:- both white clamps on the tubing connected to the sample diversion pouch and the tubing connected to the needle were closed.- the blue clamp on the tubing to the 3-1 manifold was closed - the sample pouch was full of air and the vinyl was stretched tight - with both white clamps closed, the tubing was pressure tested with a syringe filled with air in order to verify the functionality of the clamps.Both clamps were fully functional and occluded the tubing as intended.No manufacturing anomalies were noted.A review of the lot for similar reports was carried out and none have been reported.A terumo bct service representative performed a full functional check, including saline run, on the trima accel device with no unusual process variables identified.Following the check, the machine was returned for use.The run data file (rdf) was analyzed for this event.The signals in the rdf are consistent with a change in volume on the inlet side, such as an open sample bag, open donor line clamp, or improperly loaded pump header/cassette.Based on the run, it is unlikely that an open clamp on the needle line or an improperly loaded pumper header/cassette was a contributing factor.It is possible that the askew clamp on the sample bag line, as reported by the operator, only partially occluded the tubing line.A partial occlusion could allow the sample bag to fill with air.The system was then unable to reach the desired pressure for the tubing set test so the ¿pressure test error¿ alert was displayed.If the askew clamp was corrected by pinching the sides of the clamp to straighten it out without fully opening the clamp, as reported by the operator, any air in the sample bag would remain in the bag even after unloading and reloading the cassette.This would also allow the system to pass the second tubing set test.The air would remain in the sample bag until the clamp is opened, which would most likely occur when obtaining the sample following phlebotomy.Root cause: the signals in the run data file indicate that the trima accel system operated as intended by displaying the ¿pressure test error¿ alert when the system could not reach pressure during the tubing set test.The trima accel device was functionally checked and no unusual process variables were found.The trima accel tubing set was returned for investigation and no manufacturing anomalies were noted, and the clamps were fully functional and able to hold pressure.Based on the available information, the clamps on the sample bag and needle line were closed during the clamp closure verification test.The clamp on the sample bag line was bumped or manipulated, following the clamp closure verification test, resulting in a partially occluded tubing line.This could have allowed the system to pressurize the sample bag with air during the tubing set tests leading up to the ¿pressure test error¿ alert.As reported, the operator verified that the white clamps were closed and found that one of them was askew.The clamp was straightened out, but the operator did not express any air from the sample bag.Since the clamps were now closed, the system was able to complete the second tubing set test and prime the set with ac.When the donor was connected and the clamps opened, the air in the sample bag was released to the donor since the rest of the tubing set was isolated by the closure of the blue clamp.Correction: advanced operator training has been scheduled at the customer site.

Manufacturer Narrative

A voluntary medical device product recall was released by terumo bct on (b)(6) 2014 to communicate more information about the "air in the sample bag safety alert" to the customer.Corrective/preventive action: an internal capa has been initiated to address corrective and preventative actions for air in sample bag.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury on the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLT, PLS, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3995432
• MDR Text Key: 4886614
• Report Number: 1722028-2014-00301
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 05W1131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• 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 Age: 57 YR
• Patient Weight: 82