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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; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number 101025
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 06/06/2016
Event Type  malfunction  
Event Description
A patient in (b)(6) was undergoing a dialysis treatment with a cartridge blood line.During treatment there was an external blood leak noted.Limited information has been provided with regard to this event.
 
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Brand Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS S.A. DE C.V.
blvd. pacifico no. 10014
parque industrial pacifico
tijuana
MX 
Manufacturer Contact
luz del sol rodriguez
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
6646266700
MDR Report Key5781071
MDR Text Key49132340
Report Number8030638-2016-00005
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/08/2016
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? Yes
Device Operator Health Professional
Device Model Number101025
Device Lot Number1000133852
Initial Date Manufacturer Received 06/16/2016
Initial Date FDA Received07/09/2016
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
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