3ME-SC203A TSCDII 110V 3MESC203A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for 3ME-SC203A TSCDII 110V 3MESC203A manufactured by Terumo Bct.

Event Text Entries

[85599790] Investigation: the customer stated that while using the sealer device, the wafer cartridge was not loaded correctly resulting in multiple welds from the single-use wafer. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[85599813] The customer reported that a lab technician was processing two units of neonatal aliquots with thawed plasma product. While the technician was processing the neonatal aliquots, it was discovered that multiple welds were made from the single-use wafer. The customer is alleging a possible microbial contamination of the product. The customer stated that the second neonatal aliquot was discarded. Per the customer, the plasma products were collected on (b)(6) 2017 and lab processing was performed on (b)(6) 2017. (b)(6). There was not a transfusion recipient or patient involved at the time of plasma processing, therefore no patient information is reasonably known at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722028-2017-00366
MDR Report Key6832780
Date Received2017-08-30
Date of Report2017-08-30
Date of Event2017-08-06
Date Mfgr Received2018-03-14
Device Manufacturer Date2017-02-03
Date Added to Maude2017-08-30
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 FDA3
Event Location3
Manufacturer ContactSTEVE KERN
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032392246
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3ME-SC203A TSCDII 110V
Generic NameTSCDII 110V
Product CodeKSB
Date Received2017-08-30
Model Number3MESC203A
ID Number05020583300033
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-08-30

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