CRRT PRISMAFLEX NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-22 for CRRT PRISMAFLEX NA manufactured by Gambro.

Event Text Entries

[1340727] Continuous renal replacement therapy (crrt) was in recirc mode. The machine alarmed air in line. There was no air present but there was obvious sediment present. A hand crank was used to move the sediment past the air leak detector and then the machine went into "general system failure. " the circuit was taken down, data was downloaded and a new circuit was placed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1730633
MDR Report Key1730633
Date Received2010-05-22
Date of Report2010-05-22
Date of Event2010-02-16
Report Date2010-05-22
Date Reported to FDA2010-05-22
Date Added to Maude2010-06-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCRRT
Generic NameCRRT
Product CodeFII
Date Received2010-05-22
Model NumberPRISMAFLEX
Catalog NumberNA
Lot NumberNA
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age1 YR
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO
Manufacturer Address14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401


Patients

Patient NumberTreatmentOutcomeDate
10 2010-05-22

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