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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE

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GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Type  Death  
Event Description
(b)(4).
 
Manufacturer Narrative
The cartridge blood line involved in this incident was discarded and not available for investigation.
 
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Brand Name
CARTRIDGE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS S.A. DE C.V.
tijuana
MX 
Manufacturer Contact
ramon ruiz
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
645124212
MDR Report Key4562127
MDR Text Key17225530
Report Number8030638-2015-00001
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received 01/30/2015
Initial Date FDA Received03/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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