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

Catalog Number 82440

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Analysis of the run data filedid not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.However, it is possible, though not conclusive, this leukoreduction failure may have been due to a donor related phenomenon.It is also possible,though not conclusive, the frequent ¿draw pressure too low¿ alerts generated throughout this procedure may have affected the platelet product leukoreduction.Multiple low flow alerts do not automatically cause a wbc verification message to be shown at the end of run summary screens.In software version 6, the trima accel system will flag the platelet product for verification if thedonor¿s hemoglobin is higher than 17.2g/dl.In this case, at an entered hemoglobin of 16.9g/dl,the procedure was close to the flagging cut-off.It is possible, though not conclusive, the donor¿s day-of hematocrit may have exceeded the trima accel hematocrit flagging limit.Lastly, it is possible, though not conclusive a yield scaling factor (ysf) adjustment may be warranted as therun data file in question appeared to have potentially collected many more platelets than was targeted.When the collected concentrations are increased, the possibility of wbc contamination can also increase.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the 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 platelet collection is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Updated root cause: analysis of the run data file did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.It is possible, though not conclusive, this leukoreduction failure may have been due to a donor related phenomenon.This is further supported by a portion of the algorithms on the trima accel device that determine if a saturation of the lrs chamber may have occurred.This subset of algorithms set an unexpectedly high baseline, about 5 to 6 times higher than that of three donations following this one on the same trima device.When the baseline is high, it can be difficult for the system to detect excess wbc contamination, as that is determined by an increase from the baseline.The high baseline of these algorithms indicates that the lrs chamber may have been saturated with wbcs from the very beginning of the procedure or wbcs may have been escaping the lrs chamber from very early in the procedure.The high saturation flagging baseline is not necessarily a clear indicator of wbc contamination, therefore, to avoid false flagging, the high baseline itself does not flag the platelet product for verification.For example, in high concentration collections, the baseline often gets set higher than in a standard concentration collection.The baseline is determined from the rbc detector signals, so if the rbc detector readings are abnormally high due to a hot detector, the baseline may also be set higher than normal.There are other saturation detection algorithms in place that monitor for wbcs that do not utilize that baseline.The criteria of those to flag the platelet product for verification were not met throughout this procedure.It is also possible, though not conclusive, that the frequent ¿draw pressure too low¿ alerts generated throughout this procedure may have affected the platelet product leukoreduction.Multiple low flow alerts do not automatically cause a wbc verification message to be shown at the end of run summary screens.Whether the trima accel automated blood collection system flags the platelet product can depend on the timing and frequency of the ¿draw pressure too low¿ alerts, along with events and signals in the run data file that vary procedure to procedure.In software version 6, the trima accel system will flag the platelet product for verification if the donor¿s hemoglobin is higher than 17.2g/dl.In this case, at an entered hemoglobin of 16.9g/dl, the procedure was close to the flagging cut-off.It is possible, though not conclusive, the donor¿s day-of hematocrit may have exceeded the trima accel hematocrit flagging limit.Lastly, it is possible, though not conclusive a ysf adjustment may be warranted as the run data file in question and the three following appeared to have potentially collected many more platelets than were targeted.When the collected concentrations are increased, the possibility of wbc contamination can also increase.

Manufacturer Narrative

This report is being filed to provide additional information.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: analysis of the run data file did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.It is possible, though not conclusive, this leukoreduction failure may have been due to a donor related phenomenon.It is also possible, though not conclusive, that the frequent ¿draw pressure too low¿ alerts generated throughout this procedure indicated in the rdf may have affected the platelet product leukoreduction.Additionally, it is possible, though not conclusive, review of the rdf analysis shown to have potentially collected many more platelets than were targeted.When the collected concentrations are increased, the possibility of wbc contamination can also increase.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7394165
• MDR Text Key: 104549185
• Report Number: 1722028-2018-00084
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BK170059
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 82440
• Device Lot Number: 1708111130
• Other Device ID Number: 05020583824409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2017
• 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