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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION WRO 300H WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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MAR COR PURIFICATION WRO 300H WATER PURIFICATION SYSTEM FOR HEMODIALYSIS Back to Search Results
Model Number WRO300H
Device Problems Loss of or Failure to Bond (1068); Filtration Problem (2941)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/31/2016
Event Type  Injury  
Manufacturer Narrative
Facility reported two patients on (b)(6) 2016 during dialysis experienced shortness of breath, increased arterial pressures and a change in vitals. It was observed a carbon filter had the end cap come loose from the body of the carbon filter/block. The ro machine and carbon pretreatment was put into quarantine. On (b)(6) the quarantined unit was used on a patient that experienced the same symptoms. The facility reports all patients are being monitored per their policy, for one month. The carbon blocks/filters are a consumable item that are not serviced/replaced by mar cor at this facility; facility employees perform this function. Per (b)(6) guidance s&c -09-01 dialysis facilities are required to have a carbon adsorption system capable of removing both free chlorine and chloramine to safe levels (section v192). Two carbon blocks/beds are required to be installed in series, with a sample port installed after the first bed/block and after the second bed/block (section v192, also aami rd52:2004 section 5. 2. 5). This will allow a margin of safety if the first/primary carbon bed becomes exhausted, essentially the full capacity of the second bed remains available for protection against chlorine/chloramine breakthrough (section v196 and rd52 6. 2. 5). Results for chlorine /chloramine testing were not provided to mar cor, but are required at the beginning of each treatment day and also prior to each patient shift, with testing at every 4 hours if patient shifts have not been defined. It is unknown if this facility is following the recommendations and guidelines. A request was made, but the device has not been returned to mar cor. This complaint will continue to be monitored through the mar cor complaint handling system.
 
Event Description
The facility reported three (3) dialysis patients experienced symptoms of shortness of breath, increased arterial pressure and a change in vitals during dialysis. The facility suspects chlorine breakthrough.
 
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Brand NameWRO 300H
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 avenue north
minneapolis MN 55447
Manufacturer Contact
megan dickey
14550 28th avenue north
minneapolis, MN 55447
7635533300
MDR Report Key6149051
MDR Text Key61554374
Report Number3019131-2016-00002
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWRO300H
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
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