MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-02 for CARBON TANK TIMER CONTROL HEAD manufactured by Mar Cor.
[19356151]
On (b)(6) 2014 we had a major problem with our water pre-treatment equipment made by mar cor purification causing significant delays in pt treatments for hemodialysis. The timer control heads had failed on the carbon tanks which are used to remove chlorine from water used in hemodialysis. Mar cor was called in to remediate the problem and pts had to be run outside the normal treatment are on portable reverse osmosis units until the proper repairs were made. Upon closer inspection, the plunger valve on the carbon tank timer controller had corroded and was stuck causing the carbon tank not to backwash at night and regenerate. Mar cor had made a change to the part which was made of brass originally and now was made of plastic to help prevent corrosion to this critical piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041950 |
| MDR Report Key | 4667524 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-04-02 |
| Date of Event | 2014-12-11 |
| Date Added to Maude | 2015-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBON TANK TIMER CONTROL HEAD |
| Generic Name | WATER PURIFICATION SYSTEM |
| Product Code | FIP |
| Date Received | 2015-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR |
| Manufacturer Address | PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-02 |