FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ALTHIN MEDICAL, AN AFFILIATE OF BHC AF-180 HOLLOW FIBER DIALYZER   back to search results
Model Number AF-180
Event Date 10/01/2001
Event Type  Death   Patient Outcome  Death;
Event Description

Report rec'd through third party notification of legal claim. The only info presented at this time is that the pt died in 2001 and was last dialyzed the month before, on an af-180 dialyzer. No further info available.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameAF-180
Type of DeviceHOLLOW FIBER DIALYZER
Baseline Brand NameAF-180
Baseline Generic NameALTHANE DIALYZER
Baseline Catalogue Number238018
Baseline Model NumberAF-180
Baseline Device FamilyALTRAFLUX
Baseline Device 510(K) NumberK992573
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed01/18/2000
Manufacturer (Section F)
ALTHIN MEDICAL, AN AFFILIATE OF BHC
fridhemsvagen 15
p.o. box 39
ronneby
SWEDEN S-372 21
Manufacturer (Section D)
ALTHIN MEDICAL, AN AFFILIATE OF BHC
fridhemsvagen 15
p.o. box 39
ronneby
SWEDEN S-372 21
Manufacturer Contact
noemi romero-kondos
one baxter parkway
deerfield , IL 60015
(847) 948 -3796
Device Event Key383893
MDR Report Key394882
Event Key373064
Report Number1423500-2002-00630
Device Sequence Number1
Product CodeKDI
Report Source Manufacturer
Source Type Company Representative,Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 04/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberAF-180
Device Catalogue Number238018
Device LOT NumberNA01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown
Removal/Correction Number1423500-10/16/01-002R

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH