ALARIS? PUMP MODULE ADMINISTRATION SET 2426-0007

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 2020-03-28 for ALARIS? PUMP MODULE ADMINISTRATION SET 2426-0007 manufactured by Carefusion.

Event Text Entries

[188263648] Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[188263649] It was reported that the tubing separated while the bag was being changed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616066-2020-01145
MDR Report Key9892648
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-28
Date of Report2020-03-05
Date of Event2020-02-18
Device Manufacturer Date2019-10-01
Date Added to Maude2020-03-28
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 ContactMR. MUSTAFA OMAR
Manufacturer Street10020 PACIFIC MESA BLVD
Manufacturer CitySAN DIEGO CA 921214386
Manufacturer CountryUS
Manufacturer Postal921214386
Manufacturer Phone8586172000
Manufacturer G1CAREFUSION
Manufacturer Street10020 PACIFIC MESA BLVD
Manufacturer CitySAN DIEGO CA 921214386
Manufacturer CountryUS
Manufacturer Postal Code921214386
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALARIS? PUMP MODULE ADMINISTRATION SET
Generic NameSET,ADMINISTRATION,INTRAVASCULAR
Product CodeFPA
Date Received2020-03-28
Model Number2426-0007
Catalog Number2426-0007
Lot Number19105084
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-28

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