POLYFLUX LR CAPILIARY DIALYZER POLYFLUX 10 LR 104311

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 CAPILIARY DIALYZER POLYFLUX 10 LR 104311 manufactured by Gambro Dialysatoren Gmbh.

Event Text Entries

[921057] 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


[8197446] Internal blood leaks can occur due to damage to the hollow fibres. The sample has not arrived for investigation yet. The root cause can be determined after investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9611369-2008-00782
MDR Report Key1153109
Report Source06
Date Received2008-09-04
Date of Report2008-08-14
Date of Event2008-07-26
Date Mfgr Received2008-08-14
Device Manufacturer Date2007-05-01
Date Added to Maude2009-02-17
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 KRESKACH
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 CAPILIARY DIALYZER
Product CodeMSF
Date Received2008-09-04
Model NumberPOLYFLUX 10 LR
Catalog Number104311
Lot Number7-8304-H-01
ID NumberNA
Device Expiration Date2010-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO DIALYSATOREN GMBH
Manufacturer AddressHOLGER - CRAFOORD - STRASSE 26 HECHINGEN 72379 GM 72379


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-09-04

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