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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. GAMBRO DIALYSIS CASSETTE; SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE
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BAXTER HEALTHCARE CORP. GAMBRO DIALYSIS CASSETTE; SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Lot Number 1000182192
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Thrombus (2101)
Event Date 03/26/2018
Event Type  malfunction  
Event Description
On going precipitation of platelets and rbc in the hemodialysis tubing (gambro cassettes) sets.The problem was first noticed in the first week of (b)(6) 2018.The extracorporeal circuit tubings showed "white thrombus" in the venous tubings.The problem has persisted despite changing the tubing set from a different lot number and is now visible on the arterial side in some patients.No adverse events in the patient has been seen so far.All variable during in-center dialysis treatments have been tracked with no consistent finding to account for this clumping of rbc and platelets in the tubings.Suspect: yes.Primary: yes.Product type: drug/ biologic.Event abated after use stopped or dose reduced: no.Event reappeared after reintroduction: yes.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.
 
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Brand Name
GAMBRO DIALYSIS CASSETTE
Type of Device
SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
MDR Report Key7467789
MDR Text Key106955475
Report NumberMW5076811
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 04/03/2018
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 No Information
Device Lot Number1000182192
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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