SPECTRUM INFUSION PUMP 35700BAX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for SPECTRUM INFUSION PUMP 35700BAX manufactured by Baxter Healthcare Corporation.

MAUDE Entry Details

Report Number1314492-2020-01089
MDR Report Key9908546
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-18
Date Added to Maude2020-03-31
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - MEDINA
Manufacturer Street711 PARK AVE
Manufacturer CityMEDINA NY 14103
Manufacturer CountryUS
Manufacturer Postal Code14103
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRUM INFUSION PUMP
Generic NameINFUSION PUMP
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-03
Model NumberNA
Catalog Number35700BAX
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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