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

Model Number 3024326

Device Problems Device Reprocessing Problem (1091); Flushing Problem (1252); Contamination /Decontamination Problem (2895)

Patient Problem Hemolysis (1886)

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.

• Brand Name: MARCOR WATER PURIFICATION SYSTEM
• Type of Device: INDIRECT FEED SYSTEM WITH DUAL 23G ROS
• Manufacturer (Section D): MARCOR PURIFICATION ; plymouth MN
• MDR Report Key: 5001394
• MDR Text Key: 23008138
• Report Number: 5001394
• Device Sequence Number: 1
• Product Code: FIP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3024326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Distributor Facility Aware Date: 06/21/2015
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B. BRAUN DIALOG HEMODIALYSIS MACHINE
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 80