MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-26 for GAMBRO WATER PURIFICATION SYSTEM 100474 manufactured by Mar Cor Purification.
[15313763]
Mar cor purification installed a 10 cubic foot carbon tank in the clinic's pretreatment portion of the reverse osmosis water system in (b)(6) of 2013. Mcp was notified on (b)(6) 2014 that the carbon tank feed side union leaked and sprayed water on the ceiling. The water was deflected onto the top of the clinics cwp reverse osmosis water system causing the electronics and main control panel to become wet. This caused the cwp to stop generating reverse osmosis water resulting in the delay of patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[15645561]
Due to the water saturation of the electronics and main cwp ro control panel the customer was advised to replace the entire cwp ro control panel. Patients were not able to dialyze until deionized water tanks were brought online, after which all patients were able to be dialyzed. There were no reports of patient illness or injury as a result of this incident. Mar cor purification will continue to monitor this complaint within the complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2014-00032 |
| MDR Report Key | 4282249 |
| Report Source | 06 |
| Date Received | 2014-11-26 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-10-27 |
| Date Mfgr Received | 2014-10-27 |
| Date Added to Maude | 2014-12-05 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MEGAN DICKEY |
| Manufacturer Street | 14550 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7632103866 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMBRO WATER PURIFICATION SYSTEM |
| Generic Name | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Product Code | FIP |
| Date Received | 2014-11-26 |
| Model Number | 100474 |
| ID Number | 1000136 |
| Device Availability | Y |
| 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 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |