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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 CARTRIDGE
Device Problem Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 07/01/2016
Event Type  Injury  
Event Description
A patient in (b)(6) was undergoing a dialysis treatment when approximately 1 1/2 hours into treatment an internal blood leak was observed.Treatment was stopped and the blood in the extracorporeal circuit was not returned to the patient resulting in an estimated blood loss of 300 ml.Treatment continued with a new dialyzer and blood tubing.Two hours later the patient's blood pressure increased and the patient developed chest pain and chills.The patient was admitted to the icu and treated for hemolysis.The cause of the hemolysis is unknown.The date of the event is unknown therefore the date is an estimated date.
 
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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 Key5837675
MDR Text Key50900573
Report Number8030638-2016-00009
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 08/01/2016
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 NumberCARTRIDGE
Device Catalogue Number101025
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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