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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARCOR PURIFICATION MARCOR WATER PURIFICATION SYSTEM INDIRECT FEED SYSTEM WITH DUAL 23G ROS

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MARCOR PURIFICATION MARCOR WATER PURIFICATION SYSTEM INDIRECT FEED SYSTEM WITH DUAL 23G ROS Back to Search Results
Model Number 3024326
Device Problems Device Reprocessing Problem; Flushing problem; Contamination / decontamination Problem
Event Date 06/21/2015
Event Type  Injury  
Event Description

Staff recorded a chlorine level of >0. 1ppm in the water reservoir. Pts taken off dialysis early and blood in extracorporeal circuit not returned to pt.

 
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Brand NameMARCOR WATER PURIFICATION SYSTEM
Type of DeviceINDIRECT FEED SYSTEM WITH DUAL 23G ROS
Manufacturer (Section D)
MARCOR PURIFICATION
plymouth MN
MDR Report Key5001400
Report Number5001400
Device Sequence Number1
Product CodeFIP
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2015
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3024326
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/30/2015
Distributor Facility Aware Date06/21/2015
Device Age6 yr
Event Location Outpatient Treatment Facility
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/01/2015 Patient Sequence Number: 1
Treatment
B.BRAUN DIALOG HEMODIALYSIS MACHINE
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