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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008 Back to Search Results
Model Number COMBI SET
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/26/2015
Event Type  Death  
Event Description
The user facility's biomedical tech reported that pt expired during hemodialysis treatment.The user facility requested a device eval.The mfr's regional equipment specialist determined the device was operating to specs.
 
Manufacturer Narrative
This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on the info provided, it is unk how the device may have caused or contributed to the event.The post marker clinical dept is in the process of requesting add'l relevant pt medical records and treatment data regarding the reported event and a plant investigation is underway.A supplemental report will be submitted upon completion of the clinical staff's assessment of the reported info and the plant's investigation.
 
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Brand Name
FRESENIUS COMBISET 2008
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
reynosa
MX 
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
parque industrial reynosa
reynosa, tamaulipas, cp 8878 0
MX   88780
Manufacturer Contact
tanya taft, rn, cnor
920 winter st
waltham, MA 02451-1457
7816999000
MDR Report Key4553133
MDR Text Key5457537
Report Number8030665-2015-00103
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCOMBI SET
Device Catalogue Number03-2622-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2015
Initial Date FDA Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NATURALYTE,; FRESENIUS 2008T HEMODIALYSIS SYSTEM,; OPTIFLUX DIALYZER,; NATURALYTE LIQUID BICARBONATE
Patient Outcome(s) Death;
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