CGH LUNDIA ALPHA 600 (PL/CU/1.3/L) 0122606

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-03 for CGH LUNDIA ALPHA 600 (PL/CU/1.3/L) 0122606 manufactured by Gambro Healthcare.

Event Text Entries

[18601] Facility reported that there was a blood leak 1 hr into treatment. Ebl>100cc. A new dialyer was used and treatment resumed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243621-1996-00130
MDR Report Key33476
Date Received1996-05-03
Date of Report1996-05-03
Date of Event1996-04-18
Date Facility Aware1996-05-01
Report Date1996-05-03
Date Reported to FDA1996-05-03
Date Reported to Mfgr1996-05-03
Date Added to Maude1996-06-19
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCGH LUNDIA ALPHA 600 (PL/CU/1.3/L)
Generic NameDIALYZER
Product CodeFJG
Date Received1996-05-03
Catalog Number0122606
Lot Number5-0563-N
OperatorOTHER
Device AvailabilityN
Device AgeNO INFO
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key34816
ManufacturerGAMBRO HEALTHCARE
Manufacturer AddressPO BOX 101460 ATLANTA GA 30392 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-05-03

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