MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-17 for MAR COR COMPLETE WATER TREATMENT SYSTEM PVC LOOP manufactured by Mar Cor Purification.
[57682069]
Mar cor (mcp) technician arrived on a sunday to perform a dialysis loop disinfect service. Notified nurses on-site prior to starting the disinfection and received permission to start the monthly disinfect. After the loop disinfection and during the dialysis loop rinse out, the mcp technician was performing a disinfectant residual check of all the patient rooms on the 6th floor. During this rise out/residual check it was discovered a dialysis technician had started a patient on dialysis. The dialysis machine was disconnected from the water loop and the water loop port tested positive for disinfectant. Rinse out of the water loop port was performed until the residual disinfectant check showed negative. The clinic staff was notified immediately of this incident. Mcp has spoken with the clinic and has not been notified of any patient injury or patient requiring medical attention.
Patient Sequence No: 1, Text Type: N, H10
[57682070]
Potential of exposure of one dialysis patient to minncare. No patients were hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2016-00001 |
| MDR Report Key | 6034695 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-09-18 |
| Date Mfgr Received | 2016-09-18 |
| Date Added to Maude | 2016-10-17 |
| 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 | MAR COR COMPLETE WATER TREATMENT SYSTEM |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2016-10-17 |
| Model Number | PVC LOOP |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-17 |