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

Catalog Number 80400

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Hemolysis (1886)

Event Date 05/16/2016

Event Type  malfunction  

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.The run data file (rdf) was analyzed for this event.Root cause: review of the rdf indicates that the trima accel system operated as intended by displaying the ¿hemolysis detected¿ alert during the procedure based on the signals measured by the rbc detector.The rdf does not provide any additional information for investigation, it simply confirms that the alerts were triggered as designed.There is no method of differentiating between hemolysis or an rbc spillover via rdf analysis.Confirmation of hemolysis is inconclusive.The customer's observations could be related to a spillover or to actual hemolysis.An rbc spillover is generally related to an interface issue in the channel of the tubing set.Many factors can affect the interface of the fluids in the channel, including inaccurate hematocrit/hemoglobin entry, a procedure error, donor blood variables, a disposables kit issue, a machine issue, a centrifuge stop, or a tubing set loading error.Possible causes for hemolysis observed during a procedure include but are not limited to donor susceptibility (disease), needle flow rate too high, or manufacturing defects such as flash or kinks.

Event Description

The customer reported that during the first draw cycle of a platelet donation procedure, they received multiple alarms including 'hemolysis detected' alarm and noted red blood cells traveling up to the platelet bag and vent bag tubing lines.No testing was performed to confirm the alleged hemolysis.The procedure was discontinued prior to the first return cycle and rinse back to the donor was not performed.Per the customer, there was no problem with the donor and no medical intervention was necessary for this event.The patient's full identifier: (b)(6).The disposable set is not available for return, because it was discarded by the customer.

• 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: 5717829
• MDR Text Key: 48291902
• Report Number: 1722028-2016-00365
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/10/2016

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: 03/01/2018
• Device Catalogue Number: 80400
• Device Lot Number: 03Z1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 53 YR
• Patient Weight: 100