TRIMA ACCEL ENHANCED PLT, PLS, RBC SET 80449

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-15 for TRIMA ACCEL ENHANCED PLT, PLS, RBC SET 80449 manufactured by Terumo Bct.

Event Text Entries

[19996817] 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 pt involved at the time of the residual wbc testing, therefore no pt info is reasonably known at the time of the event. Donor unit #: (b)(4). The disposable set is unavailable for return because the customer discarded it. This report is being filed due to a device malfunction that has the potential for injury.
Patient Sequence No: 1, Text Type: D, B5


[20275392] (b)(4). Investigation: the run data file (rdf) was analyzed for this event. The analysis fo the rdf did not find a conclusive cause for the higher than expected wbc content in the platelet product reported for this collection. No unusual process variable was identified and the trima accel system operated as intended. Based on the available info, it is possible that the higher than expected wbc content in the platelet product could be donor related. It also cannot be ruled out that a sampling or other process error may have contributed to the higher than expected wbc content in the platelet product. Investigation eval and corrective actions are in-process. A f/u report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[21149278] (b)(4). This report is being filed to provide additional information. The device history record was reviewed. Nothing was found that was related to this event. Root cause: this disposable set was unavailable for specific root cause analysis. A definitive root cause for the observed leukoreduction failure remains undetermined at this time. Possible root causes were provided in the initial report for this event. An internal capa has been initiated to evaluate reports of elevated wbc counts.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1722028-2012-00364
MDR Report Key2631040
Report Source05
Date Received2012-06-15
Date of Report2012-05-22
Date of Event2012-05-17
Date Mfgr Received2012-09-06
Device Manufacturer Date2012-02-01
Date Added to Maude2012-10-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKRISTEN COHEN
Manufacturer Street10811 W. COLLINS AVE.
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032052870
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIMA ACCEL ENHANCED PLT, PLS, RBC SET
Generic NameAUTOMATED BLOOD CELL SEPARATOR
Product CodeLNI
Date Received2012-06-15
Catalog Number80449
Lot Number02U1118
Device Expiration Date2014-02-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.