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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
Catalog Number 101025
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 02/01/2016
Event Type  Injury  
Event Description
A patient sustained a blood loss of unknown volume when the venous needle on the cartridge blood tubing set became dislodged from the.During treatment.The patient was not symptomatic and did not require medical intervention as a result of the blood loss.Treatment was restarted using new needles.The date of the event in this report is estimated since the date of event was not provided.
 
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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
cecilia hernandez
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
6646266700
MDR Report Key5472527
MDR Text Key39415865
Report Number8030638-2016-00001
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/01/2016
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 Catalogue Number101025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2016
Distributor Facility Aware Date02/01/2016
Event Location Dialysis Unit
Date Report to Manufacturer03/01/2016
Initial Date Manufacturer Received 02/01/2016
Initial Date FDA Received03/01/2016
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
Treatment
PHOENIX SN (B)(4)
Patient Outcome(s) Required Intervention;
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