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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 04/09/2014
Event Type  Injury  
Event Description
Limited information has been provided for this event other than the patient had a cardiac history and experienced an episode during treatment that resulted in hospitalization.The clinician at the hospital states that this incident was not product related.The phoenix machine was inspected and determined to be operating within specification.The cartridge blood line was not available for inspection and the the bicart was discarded and not available for inspection.
 
Manufacturer Narrative
The blood tubing set involved in this incident was not available for investigation and the lot number could not be provided by the facility.
 
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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
ramon ruiz
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
6646266700
MDR Report Key3781963
MDR Text Key18547661
Report Number8030638-2014-00006
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 04/30/2014
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
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2014
Distributor Facility Aware Date04/09/2014
Event Location Dialysis Center
Date Report to Manufacturer04/09/2014
Initial Date Manufacturer Received 04/09/2014
Initial Date FDA Received04/30/2014
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
Patient Sequence Number1
Treatment
PHOENIX SN: (B)(4), BICART
Patient Outcome(s) Hospitalization;
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