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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION COMPLETE WATER PURIFICATION SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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MAR COR PURIFICATION COMPLETE WATER PURIFICATION SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Back to Search Results
Model Number PVC LOOP
Device Problems Component Incompatible (1108); Misassembly During Maintenance/Repair (4054)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  Injury  
Manufacturer Narrative
The facility reported a private plumber installed a brass fitting in the water loop of their complete water purification system when splicing the loop together after relocating it. There is potential for brass to leach downstream through the reverse osmosis (ro) pathway, thus potential for patient exposure during hemodialysis treatments. It was reported that the facility ran one day of patient treatments after the brass fitting was installed by the plumber. After the facility's biomed noticed the brass fitting, they reported replacing the brass fitting with a pvc or pex fitting. Ansi/aami 26722:2014 'water treatment equipment for hemodialysis and related therapies' specifically states that brass materials should be avoided due to being documented as being hazardous to the patient. Additionally, if changes are made after installation of the system, the facility is responsible for ensuring appropriate materials/components are used. While the risk to patients derives from long-term cumulative toxicity, mar cor purification has decided to conservatively submit this report due to the potential for patient exposure to brass leaching into the ro pathway. There have been no reports of patient harm. This complaint will continue being monitored in the mar cor purification complaint handling system.
 
Event Description
The facility reported a private plumber installed a brass fitting in the water loop of their complete water purification system when splicing the loop together after relocating it. There is potential for brass to leach downstream through the reverse osmosis (ro) pathway, thus potential for patient exposure during hemodialysis treatments.
 
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Brand NameCOMPLETE WATER PURIFICATION SYSTEM
Type of DeviceWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Manufacturer (Section D)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer (Section G)
MAR COR PURIFICATION
14550 28th ave n.
minneapolis MN 55447
Manufacturer Contact
alex nelson
14550 28th ave n
minneapolis, MN 55447
7635094799
MDR Report Key8380256
MDR Text Key137508414
Report Number3019131-2019-00003
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPVC LOOP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/28/2019 Patient Sequence Number: 1
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