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

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.

• Brand Name: WRO 300H
• Type of Device: WATER 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 Key: 6149051
• MDR Text Key: 61554374
• Report Number: 3019131-2016-00002
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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 Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WRO300H
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other