POLYFLUX R CAPILLARY DIALYZER POLYFLUX 17 R 109071

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 R CAPILLARY DIALYZER POLYFLUX 17 R 109071 manufactured by Gambro Diaylzatoren Gmbh.

Event Text Entries

[18223905] The customer complains about blood leak during treatment. The blood flow rate was 80ml/min, tmp, 90mhg. There was insignificant blood loss. No medical intervention was needed. No serious injury.
Patient Sequence No: 1, Text Type: D, B5


[18385850] Internal blood leaks can occur due to damage of the hollow fibres. 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 Number9611369-2008-00813
MDR Report Key1153145
Report Source06
Date Received2008-09-04
Date of Report2008-08-18
Date of Event2008-08-14
Date Mfgr Received2008-08-18
Device Manufacturer Date2008-02-01
Date Added to Maude2009-02-23
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 Phone47117-0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLUX R CAPILLARY DIALYZER
Product CodeMSF
Date Received2008-09-04
Model NumberPOLYFLUX 17 R
Catalog Number109071
Lot Number8-3552-H-01
ID NumberNA
Device Expiration Date2011-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGAMBRO DIAYLZATOREN GMBH
Manufacturer AddressHOLGER - CRAFOORD - STRASSE 26 HECHINGEN 72379 GM 72379


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-09-04

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