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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
Catalog Number 101025
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 11/20/2014
Event Type  Injury  
Event Description
After initiating a dialysis treatment on a phoenix machine and a cartridge bts, the nurse observed an external blood leak in the heparin syringe line at the welding where the luer lock attaches to the heparin tubing.The nurse stopped the heparin infusion, clamped off the line, and continued the dialysis treatment without any heparin.The treatment was uneventful and the patient did not require medical intervention or experience any adverse event from the external blood leak.The blood tubing set was discarded and not available for inspection.Ref mfr 8030638-2014-00014.
 
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Brand Name
CARTRIDGE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS S.A. DE C.V.
blvd. pacifico no. 10014
tijuana
MX 
MDR Report Key4360780
MDR Text Key5238211
Report Number2087532-2014-00045
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/20/2014,12/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number101025
Device Lot Number1000094231
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2014
Distributor Facility Aware Date11/20/2014
Device Age3 MO
Event Location Other
Date Report to Manufacturer11/20/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PHOENIX MACHINE: SN: NA
Patient Outcome(s) Other;
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