BM14 FLUID UF MODULE FOR BM25 5M3052FR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-06-22 for BM14 FLUID UF MODULE FOR BM25 5M3052FR manufactured by Edwards Lifesciences Germany Gmbh.

Event Text Entries

[2017450] A customer reported to baxter that after initial start up of the bm25, the bm14 shut off after 30 sec. The instrument could not be used for the patient treatment. No patient involvement. The instrument will be returned for investigation/repair.
Patient Sequence No: 1, Text Type: D, B5


[9155839] (b)(4). This international product is distributed outside the u. S. And does not have a 510k number, but it is being reported as it is the same or similar to a product distributed within the u. S. The actual instrument was received, evaluated and repaired. The root cause was the power supply board (230 volts). Transportation caused several condensers and diodes to loosen, resulting in voltage fluctuations and sparking. Thus, it was not possible to establish correct communication with bm14. This, in turn, caused the bm14 to switch off again, since it is controlled via the bm11.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423500-2011-08137
MDR Report Key2136889
Report Source01,04
Date Received2011-06-22
Date of Report2011-02-11
Date of Event2011-01-27
Date Mfgr Received2011-05-30
Date Added to Maude2011-12-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactVIRGINIA MCKINNEY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472702835
Manufacturer G1EDWARDS LIFESCIENCES GERMANY GMBH
Manufacturer StreetEDISONSTRASSE 3-4
Manufacturer CityUNTERSCHLEISSHEIM D85716
Manufacturer CountryGM
Manufacturer Postal CodeD85716
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBM14 FLUID UF MODULE FOR BM25
Generic NamePUMP, BLOOD, EXTRA-LUMINAL
Product CodeFIR
Date Received2011-06-22
Catalog Number5M3052FR
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES GERMANY GMBH
Manufacturer AddressD85716 GM D85716


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-22

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