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

Model Number 82300

Device Problems Complete Blockage (1094); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported an occlusion and air bubbles during a platelet collection.It is unknown at this time the location of the air bubbles or if air was returned to the donor.Patient (donor) information and outcome are not available at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the dlogs were unavailable for this event.The customer provided information about a similar incident (1722028-2020-00363).The dlog for the similar incident indicated "possible air block" because at 21 minutes into the procedure, after receiving an alarm for low platelet concentration, the operator performed an air block recovery.It is possible, however not conclusive, the customer received a similar verification flag for this procedure.The customer did not respond to requests to provide the lot number for the disposable; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause could not be determined.Possible causes for air bubbles include but are not limited to: an occlusion in the disposable set due to manufacturing error, including solvent or molding occlusions; incomplete loading of the disposable set causing an occlusion in the tubing and/or an air block, which restricted the flow.Introduction of air into the anti-coagulant (ac), saline or inlet line during or after disposable prime (if prime solution bag runs dry and air from the bag is pulled into the tubing); a kink or an occlusion in the collect line.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10379116
• MDR Text Key: 209195775
• Report Number: 1722028-2020-00368
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583823006
• UDI-Public: 05020583823006
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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 Model Number: 82300
• Device Catalogue Number: 82300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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