GAMBRO SENTRY SYSTEM 3 C-3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-06-21 for GAMBRO SENTRY SYSTEM 3 C-3 * manufactured by Gambro.

Event Text Entries

[21392515] Dialysis pt complained of abdominal pain about 2 hrs into dialysis treatment. By the end of the treatment, the pain was worsened and pt also has chest pain. Pt transferred to emergency dept where 4 consecutive blood samples were found to be grossly hemolyzed. Pt had a repeat dialysis treatment without further hemolysis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number872271
MDR Report Key872271
Report Source99
Date Received2007-06-21
Date of Report2007-06-20
Date of Event2007-06-07
Date Facility Aware2007-06-07
Report Date2007-06-13
Date Reported to FDA2007-06-20
Date Reported to Mfgr2007-06-20
Date Added to Maude2007-07-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameGAMBRO SENTRY SYSTEM 3
Generic NameHEMODIALYSIS MACHINE
Product CodeFII
Date Received2007-06-21
Model NumberC-3
Catalog Number*
Lot Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key853482
ManufacturerGAMBRO
Manufacturer Address10810 WEST COLLINS AVE. LAKEWOOD CO 80215 US

Device Sequence Number: 2

Brand NameGAMBRO CARTRIDGE
Generic NameGAMBRO DIALYSIS TUBING
Product CodeFJK
Date Received2007-06-21
Model Number*
Catalog Number003-410-510
Lot Number02N157300
ID Number*
Device Expiration Date2010-02-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key853482
ManufacturerGAMBRO
Manufacturer Address10810 WEST COLLINS AVE LAKEWOOD CO 80215 US

Device Sequence Number: 3

Brand NameEXELTRA PLUS HIGH FLUX DIALYZER
Generic NameDIALYZER
Product CodeKDI
Date Received2007-06-21
Model NumberEXELTRA PLUS 210
Catalog Number5M2132
Lot Number07C01D
ID Number*
Device Expiration Date2010-02-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No3
Device Event Key853482
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer AddressONE BAXTER PKWY DEERFIELD IL 600154625 US

Device Sequence Number: 4

Brand NameEXELTRA PLUS HIGH FLUX DIALYZER
Generic NameDIALYZER
Product CodeKDI
Date Received2007-06-21
Model NumberEXELTRA PLUS 210
Catalog Number5M2132
Lot Number07B01D
ID Number*
Device Expiration Date2010-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No4
Device Event Key853482
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer AddressONE BAXTER PKWY DEERFIELD IL 600154625 US

Device Sequence Number: 5

Brand NameMINNTECH, ACTRIL RESIDUAL TEST STRIPS
Generic NameACTRIL RESIDUAL TEST STRIPS
Product CodeMSY
Date Received2007-06-21
Model Number*
Catalog Number782558-000
Lot NumberTA705579
ID Number*
Device Expiration Date2008-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No5
Device Event Key853482
ManufacturerMINNTECH CORP.
Manufacturer Address14605 28TH AVE NORTH MINNEAPOLIS MN 55447 US

Patients

Patient NumberTreatmentOutcomeDate
101. Death 2007-06-21
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