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

Model Number 80400

Device Problems Difficult to Open or Remove Packaging Material (2922); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problems Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a platelet donation, they received an alarm and saw the platelet valve close.They checked the arm, saw blood coming from the puncture site, and observed the needle had dislodged.They did not consider the product contaminated at that time and the product was transfused.It was then found through bac-t testing that the product had been contaminated.Patient information and outcome are not available at this time.Donor unit #: w214620000098 the disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h10.Root cause: a definitive root cause for the product contamination was due to the an improperly secured needle causing needle to become dislodged from access site during procedure.The system was no longer considered a closed system as a result of the leak.A definitive root cause for the infiltration could not be determined.Possible causes include but are not limited to: poor phlebotomy technique causing the needle to unintentionally enter the tissue surrounding the blood vessel - dislodgement of the needle from the vein due to arm movement, a poorly secured needle, or an inadequate choice of venous site to puncture an excessively high return flow rate.

Event Description

Upon follow up with the customer, the customer stated that the machine alarmed and the operator noted the platelet valve closed.The operator checked the positioning of the access needle on the donor's arm and it did not appear to be dislodged.The customer asked if the valves close automatically if the needle backs out of the vein.She stated that the vein had infiltrated and the operator was instructed to end the procedure.However, the operator continued the procedure by "pushing buttons to clear the alarm".The needle backed out of the vein causing blood to leak from the donor's arm and tubing set.The donor's infiltration was treated per their sop.No medical invention was needed.There was no exposure to either the staff or the donor.Standard precautions were used to clean the machine.Blood loss was limited to the extracorporeal volume of the set.The customer confirmed that bact testing was performed on the apheresis platelets and the results were negative for microbial contamination.The customer stated that they do not have any information regarding the patient who received the platelet transfusion.Donor information is located in the patient information section.

Manufacturer Narrative

This report is being filed to provide additional information in a.1, a.2, a.3, a.4, b.5, h.6 and h.10.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The customer confirmed that bact testing was performed on the apheresis platelets and the results were negative for microbial contamination.Terumo bct customer support informed her that 'the valves do not close automatically when air is introduced into the system.The most likely alarm would be a level sensor alarm if air reaches the return reservoir.The product is air contaminated and should not be used'.A disposables history search confirmed there were no similar occurrences reported on this lot worldwide.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9910891
• MDR Text Key: 187099598
• Report Number: 1722028-2020-00141
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• 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,Followup
• Report Date: 03/27/2020

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: 11/01/2020
• Device Model Number: 80400
• Device Catalogue Number: 80400
• Device Lot Number: 1811093130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/26/2021; 04/28/2021
• Supplement Dates FDA Received: 04/12/2021; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00045 YR
• Patient Weight: 68