MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT, 35ML SAMPLER, PLS, AUTO RBC SET

Catalog Number 82668

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a trima disposable set without product bags was returned for investigation.Upon visual inspection, it was noted that the blood had circulated throughout the entire disposable set and no visible obstructions were identified.The disposable was also visually evaluated for any mis-assemblies or other defects that could have contributed to the reported incident and no anomalies were identified throughout the set components.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 10 minutes into a collection procedure, hemolysis was observed in the platelet collect bag and air divert bag.The operator stopped and aborted the procedure.Per the customer, the donor left the customer site with no apparent symptoms.The customer stated that they did not re-spin the collected product and they suspect hemolysis as the red blood cells ¿took too long¿ to settle in the platelet collect bag and air divert bag.(b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the trima accel system operated as intended.There were no spillover alerts or other alerts attributed to the rbc detector and as reported in the case, there were two leak alerts detected; one at 15 minutes, the second at 18 minutes.The time of the 2nd leak alert, the operator chose to end the procedure.A service call was conducted to check out leak alarms reported.The terumo bct service technician instructed the customer on how to check the leak detector for damage and how to clean and dry the leak detector.A simulated use test was performed, and no further alarms occurred.Additionally, preventive maintenance was performed on (b)(4) 2018 and no issues were noted.Root cause: a definitive root cause for the reported hemolysis could not be determined.According to customer statements, hemolysis was suspected because it was taking too long for rbc's to settle out.After investigation of the set returned, no hemolysis was confirmed via visual evaluation, the plasma was clear and did not contain any traces of plasma free hemoglobin.The customer had 3 leak detected alarms, and had to pause the procedure and open the centrifuge to check for leaks.When the operator resumed the procedure, some of the rbcs inadvertently entered the collect line and plasma line while the system tried to re-establish the interface.Based on the report of leak alarms during the procedure, a service call was generated to checkout the machine.Could not determine specific cause of alarms.Possible cause of leak alarms include but are not limited to:- damaged leak detector- dirty leak detector.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.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.Upon visual inspection of the returned disposable set, the blood contents in the collect pump header, collect line tubing, plasma pump header, plasma tubing appeared to have separated.It was also noted that the red blood cells (rbcs) have settled out, and the color of the plasma was clear and did not contain any traces of plasma free hemoglobin.Based on this observation, this is an rbc spillover that occurred early in the procedure and not hemolysis as alleged by the customer.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 LRS PLT, 35ML SAMPLER, PLS, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7404444
• MDR Text Key: 105249217
• Report Number: 1722028-2018-00089
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• 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,Followup,Followup
• Report Date: 04/06/2018

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: 01/01/2020
• Device Catalogue Number: 82668
• Device Lot Number: 1801263230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 04/30/2018; 10/05/2018
• Supplement Dates FDA Received: 05/01/2018; 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2018
• 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: 00063 YR
• Patient Weight: 91