POLYFLUX LR CAPILLARY DIALYZER POLYFLUX 8 LR 104333

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-09-04 for POLYFLUX LR CAPILLARY DIALYZER POLYFLUX 8 LR 104333 manufactured by Gambro Dialysatoren Gmbh.

Event Text Entries

[14868206] The customer complains about blood leak during treatment. There was insignificant blood loss. No medical intervention was needed. No serious injury.
Patient Sequence No: 1, Text Type: D, B5


[15166891] Internal blood leaks can occur due to damage of the hollow fibers. No sample is available for investigation. No further info is expected for this specific event and the case is considered closed. The root cause of this event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9611369-2008-00829
MDR Report Key1153161
Report Source06
Date Received2008-09-04
Date of Report2008-08-18
Date of Event2008-07-30
Date Mfgr Received2008-08-18
Device Manufacturer Date2007-06-01
Date Added to Maude2009-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTHOMAS KRESPACH
Manufacturer StreetHOLGER - CRAFOORD - STRASSE 26
Manufacturer CityHECHINGEN 72379
Manufacturer CountryGM
Manufacturer Postal72379
Manufacturer Phone471170
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLUX LR CAPILLARY DIALYZER
Product CodeMSF
Date Received2008-09-04
Model NumberPOLYFLUX 8 LR
Catalog Number104333
Lot Number7-8207-H-01
ID NumberNA
Device Expiration Date2010-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO DIALYSATOREN GMBH
Manufacturer AddressHOLGER - CRAFOORD - STRASSE 26 HECHINGEN 72379 GM 72379


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-04

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