MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-24 for COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS PVC LOOP manufactured by Mar Cor Purification.
[6635242]
On (b)(6) two dialysis patients were exposed to minncare. Patients were hospitalized and have been discharged.
Patient Sequence No: 1, Text Type: D, B5
[13967231]
All equipment was functioning correctly and within specification. Clinic performed investigation and suspects the distribution loop was incorrectly rinsed out by a clinic technician after disinfection with minncare. A failure to manually run both distribution loop pumps during the rinse process, could have introduced disinfectant into the loop when the pumps automatically alternated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2015-00002 |
| MDR Report Key | 4940219 |
| Report Source | 06 |
| Date Received | 2015-07-24 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-06-21 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2015-07-27 |
| 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 | 0 |
| Event Location | 0 |
| 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 | COMPLETE WATER TREATMENT SYSTEM FOR KIDNEY DIALYSIS |
| Generic Name | REVERSE OSMOSIS WATER TREATMENT SYSTEM |
| Product Code | FIP |
| Date Received | 2015-07-24 |
| Model Number | PVC LOOP |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2015-07-24 |