MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-06 for WRO 300H WRO300H manufactured by Mar Cor Purification.
[61554374]
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.
Patient Sequence No: 1, Text Type: N, H10
[61554375]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2016-00002 |
| MDR Report Key | 6149051 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-06 |
| Date of Report | 2016-11-06 |
| Date of Event | 2016-10-31 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-12-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRO 300H |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2016-12-06 |
| Model Number | WRO300H |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-06 |