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

Catalog Number 80400

Device Problems Use of Device Problem (1670); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf showed possible red blood cell spillover occurring during prime.Prime spillovers may be caused by improper loading of the kit in the centrifuge or inaccurate donor information inputted into the trima accel system.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The trima accel set is not available for return, because it was discarded by the customer.

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: review of the run data file showed that red blood cells (rbcs) were passing the rbc detector early in the run during the prime state.However, the signal measured by the rbc detector remained below the limit to trigger a prime spill over alert.The accuracy of the entered donor¿s hematocrit can affect the occurrence of a prime spillover, especially when the donor¿s hematocrit is higher than average (48%+).Another contributing factor can be loading of the channel in the centrifuge filler.If the lines exiting the hex collar become partially or fully occluded,rbcs can be sent up the plasma or platelet lines.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5930403
• MDR Text Key: 54628520
• Report Number: 1722028-2016-00497
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK150321
• 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
• Report Date: 09/06/2016

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: 02/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 02Z2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/28/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other