SET, BLOOD TRANSFUSION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-01 for SET, BLOOD TRANSFUSION manufactured by Baxter Healthcare Corporation.

Event Text Entries

[177356890] (b)(6). The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[177356891] It was reported that an unspecified quantity of blood solution sets underinfused during patient infusions. This was identified while in use with an infusion pump and further described as? The infusion pump prolongs the infusion by an additional 30 minutes?. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-00353
MDR Report Key9656425
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-01
Date of Report2020-01-31
Date Mfgr Received2020-01-07
Date Added to Maude2020-02-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE CORPORATION
Manufacturer StreetNI NI
Manufacturer CityNI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameSET, BLOOD TRANSFUSION
Product CodeBRZ
Date Received2020-02-01
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-01

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