LUNDIA ALPHA 700 N01849004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1996-10-02 for LUNDIA ALPHA 700 N01849004 manufactured by Gambro Healthcare.

Event Text Entries

[24939] During a dialysis treatment, there was an external blood leak at the sealing plug above the label. There was no pt injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5


[21794902] Investigation/determination of cause: samples received from same lot number were tested in simulated dialysis with bovine blood or a colored water solution in blood compartment of dialyzer. This test was to detect any leaks in sealing plug area. Tests are done according to requirements in ansi/aami standard for first use hemodialyzers using a pressure in blood compartment which is 1. 5 times stated maximum allowable pressure for actual device. The result from test indicated a small leak (few droplets) at sealing plug on one dialyzer when dialyzer was tested with colored water solution. No leaks occurred during test with bovine blood. Investigation of leaking dialyzer confirmed a small damage on surface of sealing plug. A review and investigation of process equipment used to manufacture plug as well as plugging station in dialyzer assembly line were done to find possible reasons for defects or small damages to sealing plug which occasionally may cause leakage. Plugging station design was reviewed and a small chage was done to plug entrance channel to facilitate movement of plug and avoid damages. Activities on plugging station were done on 10/3/96. Adjustments of complete plugging station have earlier been rechecked on 8/9/96. Follow-up action: as part of a contining improvement program, moulding tool for plug was polished to avoid any occurrence of surface roughness. This action implemented 9/2/96 will facilitate movement of plug in plug station and reduce any possibilities for random damages to plug. The mfr will continue to monitor and trend.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030992-1996-00005
MDR Report Key47653
Report Source05,06,07
Date Received1996-10-02
Date of Report1996-10-02
Report Date1996-10-02
Date Mfgr Received1996-09-03
Date Added to Maude1996-11-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameLUNDIA ALPHA 700
Generic NamePLATE DIALYZER
Product CodeFJG
Date Received1996-10-02
Model NumberLUNDIA ALPHA 700
Catalog NumberN01849004
Lot Number6-0088-L01
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key48441
ManufacturerGAMBRO HEALTHCARE
Manufacturer Address1185 OAK STREET LAKEWOOD CO 80215 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-10-02

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