MAUDE Adverse Event Report: ALL CONCETRATE PRODUCERS A-COMPONENT DIALYSIS CONCENTRATE; A-CONCENTRATE 3 MMOL/L ACETATE

Device Problems Calcified (1077); Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

A-component of classical dialysis concentrate (> acidification with 3 mmol/l acetate)
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> problem of calcification
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> so the dialysis-monitor must be descaled, the pt will not be descaled!!!
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> contribution to calcification of coronary vessels and heart valves.- with acidification with 1 mmol/l citric acid you never have calcification, as here is a second principle of working (> additional to acidification here is the chelate binding of ca++ and mg ++ to prevent calcification.
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> acetate acidification must be checked by a chemist > prohibition of acidification with acetate? you can open the dialysis fluid line in the monitor, to see and watch the calcificated deposits.So the descaling of the monitor is necessary.This critical fluid (> the prescription!) runs by back-filtration (> high-flux dialysis or with online hdf (not done in usa) in amounts up to 30 ltr./treatment) into the pt.The classical dialysis fluid (> acidification with 3 mmol/l acetate is an un-stable solution because of calcification.- with acidification with 1 mmol/l citric acid, you never have calcification.This is a chemical stable solution! so there is no need to continue the therapy with a dangerous dialysis concentrate.The increased mortality of ckd-5/rrt-patients is well known (> calcification of coronary vessels and of heart valves).The real problem of calcification of a pt beginning dialysis starts with the dialysis treatment, as for wide rages of ckd-4 pts the fgf-23 principle (> the pt's concept of increased elimination of phosphate) is working.Today there is no need to continue rrt treatment with a calcifying prescription.This is a dangerous therapy! ca++ containing phosphate-binders also contribute to calcification!), diuretics, anticoagulation with heparin.Dose or amount: 3 mmol/l acetate dialysis conc, frequency: thrice a week, route: intravenous.Dates of use: since 1978.Diagnosis or reason for use: ckd-5 - dialysis patients.

• Brand Name: A-COMPONENT DIALYSIS CONCENTRATE
• Type of Device: A-CONCENTRATE 3 MMOL/L ACETATE
• Manufacturer (Section D): ALL CONCETRATE PRODUCERS
• MDR Report Key: 3932765
• MDR Text Key: 4600204
• Report Number: MW5037229
• Device Sequence Number: 1
• Product Code: KPO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention