PHOENIX 6023006700 103453

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for PHOENIX 6023006700 103453 manufactured by Gambro Renal Products, Inc..

Event Text Entries

[184119516] Machine would not pull fluid despite being in dialysis mode. I tried several times to reset the goal and time to no avail. Another nurse cam shortly after and was able to get things to start. Machine gave an error in the beginning of "in bypass too long", but i hadn't started treatment yet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9853332
MDR Report Key9853332
Date Received2020-03-19
Date of Report2020-02-12
Date of Event2019-10-31
Report Date2020-02-12
Date Reported to FDA2020-02-12
Date Reported to Mfgr2020-03-19
Date Added to Maude2020-03-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHOENIX
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-19
Model Number6023006700
Catalog Number103453
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO RENAL PRODUCTS, INC.
Manufacturer Address1101 JETER AVENUE OPELIKA AL 36801 US 36801


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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